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  5. Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) X-ray Equipment - Attachments A through S
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Compliance Program Guidance Manual CP 7386.003 Field Compliance Testing of Diagnostic (Medical) X-ray Equipment - Attachments A through S

 LIST OF CDRH PERSONNEL TO CONTACT ON PROCUREMENT, MAINTENANCE, AND REPAIR OF INSTRUMENTATION

*    All requests for repair or replacement of instrumentation should be made through the instrumentation "HOT LINE" (30l) 443‑l736.  This phone will be answered 24 hours a day by either CDRH personnel or a recorder.  If answered by the recorder, the call will be returned if you leave your name and telephone number.  Mary Walker HFZ‑143, telephone (30l) 443‑2536 ext 137, is coordinator of field support activities and is the primary contact for questions which cannot be resolved on the "HOT LINE".

The following is a list of individuals most familiar and able to answer questions regarding equipment. 

CONTACTS:

Calibration Laboratory Shipping Address:
U.S. Food and Drug Administration
CDRH X-Ray Calibration Laboratory
10903 New Hampshire Avenue
Building 62, Room 4103
Silver Spring, MD 20993
Attn: Fred Jordan
301 796-2669

Calibration Laboratory Mailing Address:
U.S. Food and Drug Administration
CDRH X-Ray Calibration Laboratory
10903 New Hampshire Avenue
Building 62, Room 4126
Silver Spring, MD 20993
Attn: Mary Walker

Supply & Logistics Contact:
Fred Jordan
Phone: 301 796-2574
Email: fred.jordan@fda.hhs.gov

Technical Support Contacts:
Mary Walker
Phone: 301 796-2558
Email: mary.walker@fda.hhs.gov

John Wellington
Phone: 301 796-2575
Email: john.wellington@fda.hhs.gov


DO NOT return instruments to headquarters for calibration or repairs until calling the "HOT LINE" or the appropriate individual and thus obtaining instructions for return.

CDRH, OCER PERSONNEL TO CONTACT ON TEST PROCEDURES AND USE OF INSTRUMENTATION GENERAL COMMUNICATIONS LIST

Tommy Mosely: Phone 301-796-5908, Fax 301-847-8502
Nick Walker:  Phone 301-796-5910, Fax 301-847-8502

CDRH PERSONNEL TO CONTACT FOR COMPUTER DATA ENTRY PROBLEMS

Nick Walker:  Phone 301-796-5910, Fax 301-847-8502

ORA PERSONNEL TO CONTACT FOR M204 ACCOUNT AND PASSWORD

Nick Walker:  Phone 301-796-5910, Fax 301-847-8502
General Contact:  Phone 301-796-5710, Fax 301-847-8502
(Division of Mammography Quality and Radiation Programs)


CLASSIFICATION OF ITEMS OF NONCOMPLIANCE AND DEFECTS
 

Class A

Conditions which may pose a serious radiation hazard to the public health and safety.

1. An x-ray system having a malfunction such that inadvertent exposures could occur, e.g., when the exposure switch is activated, not one but repeated exposures occur, or the timer fails to terminate exposure, or exposure initiated without utilizing the exposure switch.

2. A fluoroscopic x-ray system with an entrance exposure rate of greater than or equal to 25 R/min., except:

(a) During recording of fluoroscopic images, or

(b) When an optional high level control is activated.  If the control was manufactured after May 1995, the high level entrance exposure rate is limited to 20 R/min and any reading exceeding 25 R/min is also a Class A violation.

3. A fluoroscopic system where the entire cross section of the useful beam at any SID is not intercepted by the primary protective barrier.                                                        

4. A fluoroscopic system such that x-ray production is possible when the primary protective barrier is not in position to intercept the beam.

Class B

Certified Systems and Components Only

These are conditions that (1) would result in a large amount of unnecessary radiation exposure during a routine diagnostic x-ray examination, or (2) indicate other clearly defined items of noncompliance (certified systems and components only).  These conditions may be determined in the field and calculated as in Reference 4 (the Routine Compliance Test Manual).  For purposes of regulatory follow up, Class B conditions are divided into four groups according to the degree of health hazard presented by the conditions.  The groupings are:  Substantial Hazard, Moderate Hazard, Low Hazard, and Minimal Hazard (as compared to a fully compliant x-ray system).

Substantial Hazard

1. An exposure rate beyond the plane of the image receptor, due to transmission through the primary protective barrier of a fluoroscopic x-ray system (with the attenuation block in the useful beam) of greater than or equal to 10 mR/hr for each R/min of entrance exposure rate at 10 cm from any accessible surface of the fluoroscopic imaging assembly.

2. An image‑intensified fluoroscopic x-ray system such that the total misalignment of the edges of the x-ray field with the respective edges of the visible area of the visually defined field in the plane of the image receptor is greater than 10 percent of the SID.

3. A spot film device such that the total misalignment of the x-ray field with the respective edges of the selected portion of the image receptor along the length or width dimensions of the x-ray field in the plane of the image receptor, when adjusted for full coverage of the selected portion of the image receptor, exceeds 10 percent of the SID.

4. A radiographic x-ray system having positive beam limitation where the x-ray field size in the plane of the image receptor, whether automatically or manually adjusted, is such that either the length or the width of the x-ray field differs from that of the image receptor by greater than 10 percent of the SID when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor.

5. Mobile radiographic systems where the illuminance of the light localizer is less than 96 lux at a 100 centimeter measurement distance.  

Moderate Hazard

1. For radiographic x-ray systems:

a. A radiographic x-ray system having positive beam limitation where the x-ray field size in the plane of the image receptor, whether automatically or manually adjusted, is such that either the length or the width of the x-ray field differs from that of the image receptor by greater than 5 percent of the SID and that the sum of the length and width differences without regard to sign is greater than 7 percent of the SID when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor.

b. A radiographic x-ray system providing means to align the center of the x-ray field with respect to the center of the image receptor and the misalignment is greater than or equal to 5 percent of the SID.

c. A radiographic x-ray system providing means for visually defining the perimeter of the x-ray field and the total misalignment of the edges of the visually defined field is greater than 5 percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is indicated to be perpendicular to the axis of the x-ray beam.

d. A coefficient of variation greater than or equal to 0.10 for a sample set of ten exposures as described in Reference 4.

e. A half‑value layer more than 1/2 mm aluminum below the appropriate value listed in 21 CFR 1020.30, Table I.

f. Systems equipped with positive beam limitation where at SIDs for which the device is designed to operate, it does not either cause automatic adjustment of the x-ray field to the image receptor size in the plane of the image receptor within 5 seconds after insertion of the image receptor; or if adjustment is accomplished automatically in a time interval greater than 5 seconds, or manually, does not prevent the production of x-rays until such adjustment is made.

g. An average light localizer illuminance of less than 96 lux for stationary systems and between 96 and 144 lux for mobile systems, as measured with a Digiphot at a measurement distance of 100 centimeters or the maximum SID, whichever is greater.

h. A capacitor storage system such that the standby radiation is greater than or equal to 25 mR/hr.

i. A measured kilovoltage greater or less than the manufacturer's upper or lower accuracy limits:

(1) Measured kilovoltage greater than the indicated kilovoltage A measured kilovoltage more than 105 percent of the manufacturer's upper accuracy limit for indicated kilovoltage.

(2) Measured kilovoltage less than the indicated kilovoltage A measured kilovoltage that is less than 95 percent of the manufacturer's lower limit for indicated kilovoltage.

j. Intraoral dental systems capable of operation in the above 50 kVp range, which exhibit a minimum source to skin distance less than 16 centimeters.

k. Intraoral dental systems capable of operation in the above 50 kVp range for which the field size at the cone tip is greater than or equal to 9 centimeters.

l. Dental radiographic systems in which it is possible to produce x-rays with the timer in the zero or off position.

m. Mammographic x-ray systems in which the edge of the x-ray field at the chest wall extends beyond the edges of the image receptor by more than 5 percent of the source to image receptor distance.

2. For fluoroscopic x-ray systems:

a. An image‑intensified fluoroscopic x-ray system such that the total misalignment of the edges of the x-ray field with the respective edges of the visually defined field in the plane of the image receptor is equal to or greater than 6 percent, but less than 10 percent of the SID, and the sum, without regard to sign, of the misalignment along any two orthogonal dimensions intersecting at the center of the visible area of the image receptor is equal to or greater than 8 percent of the SID.

b. A nonimage‑intensified fluoroscopic system such that any dimension of the x-ray field extends beyond the visible portion of the image receptor by greater than 8 percent of the SID.

c. For conditions described in 21 CFR 1020.32(d), if the maximum allowable entrance exposure rate is 5 R/min., test values of greater than or equal to 5.6 R/min., but less than 25 R/min.  Correspondingly, for a maximum allowable rate of 10 R/min., test values of greater than or equal to 11.5 R/min. but less than 25 R/min. are included.

d. Half‑value layer values that are more than 1/2 mm below the value specified in 21 CFR 1020.30 Table I.

e. An exposure rate due to transmission through the primary protective barrier of a fluoroscopic system with the attenuation block in the useful beam of greater than or equal to 4 mR/hr but less than 10 mR/hr for each R/min of entrance exposure rate at 10 cm beyond the plane of the image receptor.

f. A spot film device such that the total misalignment of the x-ray field with the respective edges of the selected portion of the image receptor along the length or width dimensions of the x-ray field in the plane of the image receptor, when adjusted for full coverage of the selected portion of the image receptor, exceeds 6 percent, but is less than 10 percent of the SID.  The sum without regard to sign of the misalignment along any two orthogonal dimensions exceeds 7 percent of the SID.

g. Stationary fluoroscopes with a minimum source‑to‑skin distance of less than 35.2 centimeters.

h. Mobile fluoroscopes with a minimum source-to-skin distance of less than 27.2 centimeters or 18.1 centimeters when configured for surgical use (e.g. spacer removed).

i. For controls manufactured after May 1995, which have high level controls limited to 20 R/min, test values of greater than 21.5 R/min  but less than 25 R/min.

j. Other similar situations.

Low Hazard

1. For radiographic x-ray systems:

a. A coefficient of variation greater than or equal to 0.084 for a sample set of four exposures, or between 0.06 and 0.10 for a sample set of ten exposures as described in Reference 4.

b. A linearity value of greater than or equal to 0.153.  This value is based upon two sample sets of at least four exposures each, as described in Reference 4.

c. A radiographic x-ray system having indicated field size dimensions such that aperture adjustments result in x-ray field dimensions that differ from those of the image receptor by equal to or greater than 5 percent of the SID when the beam axis is intended to be perpendicular to the plane of the image receptor.

d. A stationary general purpose radiographic x-ray system (i.e., one equipped with stepless adjustment of the size of the x-ray field) such that the actual SID differs from the indicated SID by more than 5 percent of the indicated SID.  These values are based on a test procedure using a direct measurement of the distance from the focal spot to the tabletop and from the tabletop to the film plane as described in Reference 4.

e. For stationary systems only, an average light localizer illuminance of between 96 and 144 lux as measured with a Digiphot.

f. A capacitor storage radiographic system such that the standby radiation is greater than 3.0 mR/hr, but less than 25 mR/hr.

g. Systems equipped with positive beam limitation devices that do not allow the field size to be reduced to a size less than that of the image receptor.

h. Systems equipped with positive beam limiting devices that do not provide for an automatic return to PBL from a reduced field size.

i. Mobile radiographic systems for which the minimum source to skin distance is less than 27.5 centimeters.

j. Mammographic systems for which the edges of the x-ray field on any side extend beyond the edge of the image receptor by more than 5 percent of the SID.

k. 

(1) When the maximum operating range is above 70 kVp; a half‑value layer (HVL) between (0.15 + 0.04 x HVL) mm and 0.5 mm aluminum below the appropriate value listed in 21 CFR 1020.30 Table I.

(2) When the maximum operating range is 50 to 70 kVp:  a half‑value layer (HVL) between (0.08 + 0.04 x HVL) mm and 0.5 mm aluminum below the appropriate value listed in 21 CFR 1020.30 Table I.

(3) When the maximum operating range is less than 50 kVp:  a half‑value layer (HVL) between 0.1 mm and 0.5 mm aluminum below the appropriate value listed in 21 CFR 1020.30 Table I.

l. Systems equipped with positive beam limitation, which do not prevent the production of x-rays at SID's greater than 36 inches where the PBL device is not intended to operate.

2. For fluoroscopic x-ray systems:

a. Fluoroscopic systems equipped with high level control that do not provide an audible indication of the activation of the high level control.

b. Half‑value layer (see item k(1) under radiographic systems).

c. Systems which do not provide either continuous audible signal or termination of x-rays at the completion of a previously selected time interval.                     

Class B

Uncertified Systems and Components Only

Other situations similar to those of Class B certified systems and components, which in the judgement of the auditor constitute a defect as defined in 21 CFR 1003.2(b).

Class C

Certified Systems and Components Only

These are conditions that indicate test results exceeding the requirements of the standard but less than the values for Class B noncompliances for certified systems and components only.  These may be determined in the field and calculated as in Reference 4.

1. For radiographic x-ray systems:

a. A radiographic x-ray system having positive beam limitation where the x-ray field size in the plane of the image receptor, whether automatically or manually adjusted, is such that either the length or the width of the x-ray field differs from that of the image receptor by 3.00 to 4.99 percent of the SID and that the sum of the length and width differences without regard to sign is between 4.00 and 6.99 percent of the SID when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor.

b. A radiographic x-ray system providing means to align the center of the x-ray field with respect to the center of the image receptor and misalignment is between 2.00 and 4.99 percent of the SID.

c. A radiographic x-ray system providing means for visually defining the perimeter of the x-ray field and the total misalignment of the edges of the visually defined field is between 2.00 and 4.99 percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is indicated to be perpendicular to the axis of the x-ray beam.

d. A radiographic x-ray system having indicated field size dimensions such that aperture adjustments result in x-ray field dimensions that differ from those of the image receptor by between 2.00 and 4.99 percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor.

e. A stationary radiographic x-ray system providing means for stepless adjustment of the size of the x-ray field such that the actual SID is either larger or smaller than the indicated SID by between 2.00 and 4.99 percent.  These values are based on a test procedure using direct measurement of the distance from the focal spot to the tabletop and from the tabletop to the film plane as described in Reference 4.

f. A coefficient of variation greater than 0.050 but less than 0.084.  This value is based upon a sample set of four exposures.  When a set of ten exposure values is made, the upper limit is reduced from 0.084 to 0.06 (see Reference 4).

g. Linearity value of greater than 0.100 but less than 0.152.  This value is based upon two sample sets of at least four exposures each, as described in Reference 4.

h. 

(1) When the maximum operating range is above 70 kVp: A half‑value layer (HVL) below the appropriate value listed in 21 CFR 1020.30, Table I, but less than (0.15 + 0.04 X HVL) mm Al below the listed value.

(2) When the maximum operating range is 50 to 70 kVp: A half‑value layer below the appropriate value listed in 21 CFR 1020.30, Table I, but less than (0.08 + 0.04 X HVL) below the listed values.

(3) When the maximum operating range is less than 50 kVp:  A half‑value layer (HVL) below the appropriate value listed in 21 CFR l020.30 Table I but less than 0.1 mm Al below the listed value.

i. An average light localizer illumination greater than 144 but less than 160 lux as measured with a Digiphot.

j. A capacitor energy storage radiographic system such that the standby radiation is greater than 2.0 mR/hr but less than 3.0 mR/hr.

k. A measurable kilovoltage greater or less than the manufacturer's upper or lower accuracy limits.

(1) Measured kilovoltage greater than indicated kilovoltage A measured kilovoltage ranging from the manufacturer's upper accuracy limit to a measured kilovoltage such that 95 percent of this value is greater than the upper accuracy limit.

Example:  The indicated kilovoltage on the x-ray control is 100 kVp.  If the manufacturer states an accuracy of + 10 percent, the upper and lower accuracy limits would be 110 kVp and 90 kVp, respectively.  In this case, a measured kilovoltage ranging from 110 kVp to 115.8 kVp would be a Class C noncompliance.

(2) Measured kilovoltage less than indicated kilovoltage A measured kilovoltage ranging from the manufacturer's lower accuracy limit to a measured kilovoltage such that 105 percent of this value is less than the lower accuracy limit.

Example:  The indicated kilovoltage on the x-ray control is 100 kVp.  If the manufacturer states an accuracy of + 10 percent, the upper and lower accuracy limits would be 110 kVp and 90 kVp, respectively.  In this case, a measured kilovoltage ranging from 90 kVp to 85.7 kVp would be a Class C noncompliance.

2. For fluoroscopic x-ray systems:

a. An image‑intensified fluoroscopic x-ray system such that the total misalignment of the edges of the x-ray field with the respective edges of the visible area of the visually defined field in the plane of the image receptor is greater than 3 percent but less than 6 percent of the SID, and the sum, without regard to sign, of the misalignment along any two orthogonal dimensions intersecting at the center of the visible area of the image receptor is greater than 4 percent but less than 8 percent of the SID.

b. A nonimage‑intensified fluoroscopic system such that any dimension of the x-ray field extends beyond the visible portion of the image receptor but by less than 8 percent of the SID.

c. For conditions described in 21 CFR l020.32(d), if the maximum allowable entrance exposure rate is 5 R/min., test values of greater than 5.0 R/min., but less than 5.6 R/min.  Correspondingly, if the maximum allowable entrance exposure rate is 10 R/min., test values of greater than 10.0 R/min. but less than 11.5 R/min. are included.

d. Half‑value layer (see h(1) under radiographic x-ray systems this section).

e. An exposure rate due to transmission through the primary protective barrier of a fluoroscopic system with the attenuation block in the useful beam of greater than 2.0 mR/hr but less than 4.0 mR/hr for each R/min. of entrance exposure rate at 10 cm beyond the plane of the image receptor.

f. A spot film device such that total misalignment of the x-ray field with the respective edges of the selected portion of the image receptor along the length or width dimensions of the x-ray field in the plane of the image receptor, when adjusted for full coverage of the selected portion of the image receptor, is greater than 3 percent but less than 6 percent of the SID.  The sum without regard to sign of the misalignment along any two orthogonal dimensions is greater than 4 percent but less than 7 percent of the SID.

g. For controls manufactured after May 1995 that contain high level controls, where the maximum allowable entrance exposure rate is 20 R/min, test values greater than 20 R/min, but less than 21.5 R/min.

h. Stationary fluoroscopes with a minimum source‑to‑skin distance between 35.2 centimeters and 38 centimeters.

i. Mobile fluoroscopes with a minimum source-to-skin distance between 27.2 centimeters and 30 centimeters or between 18.1 centimeters and 20 centimeters when configured for surgical use (e.g. spacer removed).

j. Other similar situations.

 

Class C

Uncertified Systems and Components Only

Other situations similar to those of Class C certified systems and components which in the judgment of the auditor meet the definition of 21 CFR 1003.2(b).

Class D

All items that indicate a system in compliance.

Class E

These items are minor functional noncompliances which may not be assembler related.  They do not warrant a Notification letter by themselves, but may be included in a Notification letter issued because of other violations (similar to notification of Class C violations).

Minimal Hazard

1. For radiographic systems:

a. Stationary systems where there are no means to indicate when the beam axis is perpendicular to the plane of the image receptor.

b. Stationary systems where means are not provided to center the diagnostic source assembly over the image receptor.

c. Systems where technique factors are not indicated at the operator's position.

d. Systems which lack a warning label.

2. For fluoroscopic systems:

a. No warning label present on the master x-ray control panel.

b. Systems where the tube potential and tube current are not continuously indicated during x-ray exposure

SAMPLE REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM (FDA-2579)

Hard copy of the Report of Assembly of a Diagnostic X-Ray System

 FORM FD-2766 CLAIM FOR DAMAGES TO ELECTRONIC PRODUCTS

Copy of Form FD-2866 Claim for Damages to Electronic Products

CONTACTS FOR MANUFACTURERS OF DIAGNOSTIC X-RAY SYSTEMS CONTROLS

When a noncompliance is discovered through routine diagnostic x-ray field testing under this program, a courtesy copy of the findings should be sent to the component manufacturer associated with the violation.  Generally systems are tracked by the master control.  The name and address of the component manufacturer should be provided on a tag/label permanently affixed or inscribed on the component.

To obtain the most recent address for the manufacturers of diagnostic x-ray components search the FDA web site for medical devices databases under establishment registration.  The site may be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/registration.cfm.  The courtesy copy should be sent to the address that is listed for the official correspondent or the US Agent.  Additionally, FACTS may be searched (Navigate/Firms/Firms Search) to obtain the current address for the component manufacturer.  FACTS searches to locate a domestic manufacturer require you provide the manufacturer’s state.  FACTS searches to locate a foreign manufacturer require you provide the manufacturer’s country and the first three letters of the city.


NOTIFICATION LETTER TO THE ASSEMBLER (INCOMPLETE OR INCORRECT FDA-2579 REPORT OF ASSEMBLY)

CERTIFIED MAIL

RETURN RECEIPT REQUESTED 

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM'S COMPLETE ADDRESS

 

Dear (Addressee)

On (date) your firm was inspected/contacted by (investigator) from our (Location) District office.  At that time, he  (she or they)  explained to you  (or name & title of agent) your firm's responsibility as an assembler to submit complete and accurate Reports of Assembly of a Diagnostic X-ray System, Form FDA 2579, for each certified diagnostic x-ray component (system) installed by your firm. 

Accurate and complete Reports of Assembly of a Diagnostic X-ray System, Form FDA 2579, are required to be submitted to FDA within 15 days following the completion of assembly pursuant to 21 CFR 1020.30 (copy enclosed)

We are requesting that you provide us with a corrected Report of Assembly of a Diagnostic X-ray System, Form FDA 2579, within 30 working days of the receipt of this letter for (FDA 2579 number), which is for equipment assembled at (location). A copy of the report you previously submitted is enclosed. 

Along with a corrected FDA 2579, you should notify this office in writing, within 30 working days of receipt of this letter, of the specific steps you have taken to prevent the recurrence of similar violations.  Your response should be sent to (name) , Compliance Officer, Food and Drug Administration,  (street address) , (city) , (state & zip code) .  If you have any questions,  (name)  can be contacted at  (telephone #).

 

                                                                 Sincerely,

                                         

                                                                 District Director


NOTIFICATION LETTER TO ASSEMBLER - STANDARDS VIOLATIONS FOUND DURING REVIEW OF FDA-2579's OR RECORDS REVIEW AT THE ASSEMBLER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED
 

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM'S COMPLETE ADDRESS

 

Dear (Addressee)

During an inspection of your firm located at (address), conducted on (date) , our investigator(s) determined that your firm is an assembler of diagnostic x-ray equipment.  At that time, he (she or they)  specifically discussed your assembly of a (type of x-ray system i.e. general purpose radiographic)  unit at  (location)  and explained to you that your installation of a  (x-ray system component, e.g., beam limiting device which does not provide variable beam limitation on such a unit) was in violation of  (identify regulation, e.g., 21 CFR 1020.31(d)(1)).

 At that time you agreed to replace (component, e.g., the beam limiting device) with the type called for by the standard (e.g., required standard i.e. variable x-ray field limitation) , and submit a corrected Report of Assembly of a Diagnostic X-ray System, Form FDA 2579 to the Food and Drug Administration, the State Radiation Control Program, and the purchaser by (date).  Please use the enclosed forms for this purpose.  We have enclosed an envelope for your use in returning the original (white) copy directly to this office.

 Subsequent to (date agreed upon), a representative of the Food and Drug Administration may investigate your assembly at (location) to verify your correction. 

Failure to correct a defect or noncompliance or failure to file a Report of Assembly of a Diagnostic X-ray System, Form FDA 2579, is a violation of the Federal Food, Drug, and Cosmetic Act (the Act), section 538 of Subchapter C ‑ Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of l968)

Accurate and complete Reports of Assembly of a Diagnostic X-ray System, Form FDA 2579, are required to be submitted to FDA within 15 days following the completion of assembly pursuant to 2l CFR l020.30. 

Along with a revised FDA 2579, you should notify this office in writing, within 30 working days of receipt of this letter, of the specific steps you have taken to correct the noted violation(s), including an explanation of each step taken to prevent the recurrence of similar violations.  If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed.  Your response should be sent to (name), Compliance Officer, Food and Drug Administration,  (street address),  (city),  (state & zip code) . If you have any questions, (name) can be contacted at  (telephone #) .

 

 

 

                                                                              Sincerely,

 

                                                                              District Director

                                                                                                                 

Enclosures


NOTIFICATION LETTER TO ASSEMBLERS (FAILURE TO FILE FDA 2579 REPORTS OF ASSEMBLY)

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED 

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM'S COMPLETE ADDRESS

 

Dear (Addressee)

During an inspection of your firm located at (address) , conducted on (date) , our Investigator(s) determined that your firm is an assembler of diagnostic x-ray equipment.  At that time, he (she or they) explained to you  (or to your agent)  your responsibility to file a Report of Assembly of a Diagnostic X-ray System, Form FDA 2579, for each certified diagnostic x-ray component  (system)  you assemble (see attached copy of applicable regulations).  We have identified the following facility(s) for which your assembly was not reported to FDA in accordance with 21 CFR 1020.30: 

     1.   (name and location)

 

     2.   (name and location)

 

                 etc. 

Accurate and complete Reports of Assembly of a Diagnostic X-ray System, Form FDA 2579, are required to be submitted to FDA, the appropriate State Radiation Control Program, and the purchaser within 15 days following the completion of assembly pursuant to 21 CFR 1020.30.  

Failure to file a Report of Assembly of a Diagnostic X-ray System, Form FDA 2579, is a violation of the Federal Food, Drug, and Cosmetic Act (the Act), section 538 of Subchapter C ‑ Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of l968). 

Along with a FDA 2579 for each of the above listed installations, you should notify this office in writing, within 30 working days of receipt of this letter, of the specific steps you have taken to prevent the recurrence of similar violations.  Your response should be sent to  (name) , Compliance Officer, Food and Drug Administration,  (street address) ,  (city) ,  (state & zip code) .  If you have any questions, (name)  can be contacted at  (telephone #).

 

                                                                              Sincerely yours,

 

                                                                              District Director

Enclosures


NOTIFICATION LETTER TO THE ASSEMBLER (NOTIFICATION OF DEFECT OR NONCOMPLIANCE AS THE RESULT OF FIELD TESTING) 

NOTE: This letter is a model letter for use under the audit review program [See Regulatory  Procedures Manual, Chapter 4, Exhibit 4-1, Section 6.4] and is located at ORA’s Office of  Enforcement “Warning Letters and Untitled Letters Main Page” (http://web.ora.fda.gov/oe/tempdoc.htm).

                        [When letter contains Class A violations: WARNING LETTER]                                               

 

[DATE] 

Via Federal Express—Next Day 

Most Responsible Individual at Company, Title

Company

Address

City,  State  Zip

 

Re:   Field Test Number GI-_______ 

 

Dear __________:

 

On ___________, 200X, a representative from the Food and Drug Administration (FDA) conducted a field test of the certified diagnostic x-ray system at the following facility:

 

          Name of Facility:

                        Address:

                        City, State  Zip: 

                        X-Ray Control Manufacturer:

                        X-Ray Control Model/ Serial No.: 

                        Room No.: 

Our records indicate that your firm assembled this system (FDA-2579; _____) on _______ , and we tested this system to determine its compliance with portions of the Performance Standard for Diagnostic X-Ray Equipment (21 C.F.R. §§ 1020.30-32).  Diagnostic x-ray equipment is a device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). 

[WHEN YOU HAVE A CLASS A VIOLATION INSERT THE FOLLOWING:]

 

This letter confirms our telephone notification on              to Mr./Ms. [Most Responsible Individual] of

your firm.  During this telephone call, we requested that you immediately correct the following serious non-compliance(s) with the performance standard:

 

            [Indent and list Class A violations in numbered or bullet-pointed paragraphs]

 

[WHEN YOU HAVE A CLASS B VIOLATION INSERT THE FOLLOWING:] 

Our analysis of the field test data indicates that the system does not comply with the following items of the performance standard:

           

            [Indent and list Class B violations in numbered or bullet-pointed paragraphs]

 

[WHEN YOU HAVE A DEFECT, ADD THE FOLLOWING:]

 

While conducting our field test, we also determined that the system was defective in the following manner:

 

            [Indent and list defects, as defined in 21 CFR § 1003.2, in numbered or bullet-pointed paragraphs]

 

WHEN YOU HAVE A CLASS C VIOLATION AND YOU ARE ALSO DECLARING CLASS A  AND/OR B VIOLATIONS OR A DEFECT, ADD THE FOLLOWING: 

In addition to the above problems, we consider the compliance status of the following items to be suspect.  Please verify the compliance status of these items when you correct the previously cited problems.

 

            [Indent and list Class C violations in numbered or bullet-pointed paragraphs]                       

We request that you, as the responsible assembler, investigate the deviation(s) from the performance standard and/or the defects listed above in accordance with 21 C.F.R. §§ 1003 and 1004, as follows: 

1.      If you determine that the deviation and/or defect is caused by improper assembly or installation, you should correct the deviation and/or defect at no charge to the user by either repairing the system, replacing it, or refunding the cost. 

2.      If you determine that the deviation and/or defect is caused by the factory-based manufacturer, you should notify the manufacturer of the deviation and/or defect and send documentation of such notification to this office. 

3.      If you can establish that the system is compliant, that the alleged deviation and/or defect does not exist or does not relate to the safety of the product, or is directly attributable to user abuse or lack of maintenance, you may submit such evidence to this office in accordance with 21 C.F.R. § 1003.11(a)(3) within [if letter includes Class A violations: fifteen (15);  if letter does not include Class A violations thirty (30)] working days of receipt of this letter. 

You are requested to report the results of your investigation and follow-up action to this office within [if letter includes Class A violations: fifteen (15);  if letter does not include Class A violations thirty (30)] working days of the receipt of this letter.  Your response should include the date that the corrective actions were completed, and a copy of the service record and/or other supportive documents. [if letter does not include Class A violations, insert the following:] Failure to respond may constitute a violation of the Act, Sections 538(a)(2) and 538(a)(4) of Sub-chapter C - Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968).   

[Include the following only when letter contains Class A violations:] 

Failure to respond constitutes a violation of the Act, Sections 538(a)(2) and 538(a)(4) of Sub-chapter C - Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968).  Failure to promptly correct this violation can result in regulatory action being initiated by FDA without further notice.  These actions include seizure, injunction, and the imposition of civil penalties as provided for in Section 539 of the Act.  Persons violating Section 538 of the Act are subject to civil penalties of up to $1,000 per violation and up to a maximum of $300,000. 

Your response should be sent to _____________, Compliance Officer, Food and Drug Administration, Address.  If you have any questions, please contact  ______________ , telephone number, extension.

 

                                                                        Sincerely,

 

                                                                        Director of Compliance

                                                                        District Office 

 

cc:     Facility Representative

            Facility

            Address

            City, State Zip

 

FIELD CORRECTION STATUS REPORT  

X-RAY FIELD TEST NON-COMPLIANCES THAT ARE UNRESOLVED IN ATLANTA HOME DISTRICT

 

         TEST      ACCOMP       FACILITY/ZIP

TEST ID  DATE     DISTRICT      ASSEMBLER/ZIP                       NONCOMPLIANCES

-------  ----     -------       ------------                          ------------

AR56175R 19961009  LOS          MOBILE LITHOTRIPTERS/92630                          

                                DORNIER MEDICAL SYSTEMS INC./30144     Q07 Q08 Q71

AR54497A 19961018  ATL          NORTHSIDE HOSPITALL/30342                         

                                PICKER INTERNATIONAL/30071             9

UF55410B 19961029  NOL          VICKSBURG MEDICAL CENTER/39180                      

                                GENERAL ELECTRIC COMPANY/30071         10

UF55415B 19970123  NOL          MONFORT JONES MEMORIAL HOSPITAL/39090             

                                PICKER INTERNATIONAL/30071             8 9

AR64877A 19970127  ATL          PROMINA PRIMARY CARE CENTER/30060                 

                                RAMSEY ENTERPRISES INC./30188          Q54

AR56372A 19970130  ATL          THE PAPP CLINIC/30265                             

                                X-RAY OF GEORGIA, INC./30071           2

UF56357B 19970214  ATL          KAISER PERMANENTE, SPMO/28210                   

                                GENERAL ELECTRIC COMPANY/30071         16

AR37356A 19970305  NOL          HUEY P. LONG REGIONAL MED CNT/71360             

                                GENERAL ELECTRIC COMPANY/30071         3

AR55416  19970312  NOL          BAPTIST MEMORIAL HOSPITAL/38671           

                                UNKNOWN (CFN: 1043749)                 3 5

AR57378A 19970318  ATL          CANDLER HOSPITAL/31405                              

                                GENERAL ELECTRIC COMPANY/30071         3

AR58973A 19970319  ATL          CANDLER HOSPITAL/31405                              

                                GENERAL ELECTRIC COMPANY/30071         3

AR58972A 19970320  ATL          MEDICAL CENTER LLP/31021                          

                                X-RAY OF GEORGIA, INC./30071           9

AR50490A 19970509  NSV          ST. CLAIRE REGIONAL HOSPITAL/35125                  

                                UNKNOWN (CFN: 1056430)                 Q54 Q69 Q70

AR57884A 19970515  ORL          MORTON PLANT MEASE HOSPITAL/34698                   

                                GENERAL ELECTRIC COMPANY/30071         Q71

UF57943B 19970611  ORL          MIAMI CHILDRENS HOSPITAL/33155                      

                                GENERAL ELECTRIC COMPANY/30071         12

AR43600A 19970616  NSV          QUANTUM IMAGING/37203                               

                                GENERAL ELECTRIC COMPANY/30071         9 33 35

UF64654C 19970909  ORL          CEDARS MEDICAL CENTER/33136                         

                                GENERAL ELECTRIC COMPANY/30071         10

AR64057A 19971030  NOL          FOREST GENERAL HOSPITAL/30401                       

                                GENERAL ELECTRIC COMPANY/30071           35

AR57336A 19971112  ATL          OCONEE MEMORIAL HOSPITAL/29679                      

                                PHILIPS MEDICAL SYSTEMS, INC./28217    29 31

AR57337A 19971112  ATL          OCONEE MEMORIAL HOSPITAL/29672                      

                                PHILIPS MEDICAL SYSTEMS, INC./28217    17 19 21

 

 

 

TOTAL FIELD TEST RECORDS FOR ATLANTA HOME DISTRICT IS: 21

NOTIFICATION LETTER TO THE USER (NOTIFICATION OF NONCOMPLIANCE ATTRIBUTABLE TO USER ACTIONS OR INACTION)

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM'S COMPLETE ADDRESS

 

Dear (Addressee)

On (date), a field test was performed on the (name of mfr.) diagnostic x-ray system, control model number (model number), located in room (number) of your facility.  We tested this system to determine its compliance with portions of the Performance Standard for Diagnostic X-ray Equipment (Title 21, Code of Federal Regulations (CFR), sections 1020.30‑32).   

Analysis of the data obtained from the field test shows the system fails to comply with the following requirements of the Federal performance standard for diagnostic x-ray systems: 

               (Describe Each Item of Noncompliance)

Our investigation indicates that neither the manufacturer nor the assembler is likely to be responsible for these noncompliances under the regulations.  The use of a noncompliant x-ray system may result in unnecessary radiation exposure to the patient or operator.  Therefore, we encourage you to arrange for correction of the noncompliance.

     (If Class A Conditions are Involved, Substitute the Following) 

Our investigation indicates that neither the manufacturer nor the assembler is likely to be responsible for the noncompliances under the regulations.  These problems may pose a serious health hazard to the patient or operator.  We strongly encourage you to discontinue use of the system and arrange for its repair immediately.

 You are hereby requested to notify this office in writing, within 30 working days of receipt of this letter, of the specific steps you have taken to correct the noted noncompliance.  If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed.  Your response should be sent to  (name) , Compliance Officer, Food and Drug Administration, (street address) ,  (city) ,  (state & zip code).  If you have any questions,  (name)  can be contacted at  (telephone #) .

 

                                                                              Sincerely yours,

                                                                              District Director

NOTE:  Indicate at the bottom of the original letter that the state radiation control program has received a copy of this letter.


RESPONSIBILITY FOR DEFECTS AND NONCOMPLIANCES

The Diagnostic X-ray Performance Standard specifies certain limits of responsibility for manufacturers and assemblers of x-ray equipment.  Assemblers are responsible for noncompliances that are attributed solely to improper assembly or installation or caused by improperly following the instructions provided by the manufacturer.  Manufacturers are responsible for noncompliances caused by improper assembly  if adequate instructions were not provided to the assembler (21 CFR 1020.30(c)).  The performance standard does not specifically address the limits of responsibility regarding equipment age or user responsibility. 

Manufacturers are required by the performance standard to provide purchasers with a schedule of maintenance necessary to keep the x-ray equipment in compliance with the performance standard (21 CFR 1020.30(h)(1)(ii)).  The regulations require manufacturers to provide a maintenance schedule because it is unreasonable to expect x-ray equipment to meet certain performance requirements if proper maintenance is not performed.  After the first maintenance is performed or after the time it should have been performed, the assembler may no longer be responsible for requirements affected by proper adherence to the maintenance schedule.  Some assemblers of older certified equipment will correct the noncompliance and bill the owner rather than attempting to refute responsibility for the noncompliance.  This practice frequently upsets the x-ray system owner since he believes this work should have been performed free of charge. 

Evidence that would exempt manufacturers/assemblers from responsibility includes: 

1. Failure by the user to follow the manufacturer's prescribed maintenance schedule for those items requiring periodic adjustment.

2. Photographs or other documentation (written description) of physical damage to the x-ray system, which was due to abuse. 

The manufacturer/assembler may be held responsible if the user has failed to follow the maintenance schedule but the facility has documented continued compliance problems with the system beginning in the warranty period. 

Items that may require periodic adjustment under a manufacturer's maintenance schedule include:   

a) linearity

b) x-ray field/light field alignment

c) PBL sizing

d) illuminance

e) entrance exposure rate

f) fluoroscopic alignment

g) spot film alignment

h) indication of technique factors

i) signal and warning lights

Some items require adjustment on a time basis while others require adjustment at time of a tube reloading or bulb change in the collimator lamp.  The individual maintenance schedule must be checked to determine the applicable situation and time interval.


LIST OF QUALIFIED X-RAY AUDITORS 

District Name(s) Phone Number/Fax Number
New England District

Michael J. Leal

George Allen

508-793-0422

508-793-0422

New York District James Wormuth

518-453-2314x30

513-453-2443

Baltimore District Jeffrey Sincek* 614-487-1273x16
614-487-9658
Cincinnati District

Terry R. Bolen

Jeffrey Sincek*

513-679-2700x138
614-487-1273x16
New Jersey District Jeffery Sineck 614-487-1273x16
614-487-9658
Philadelphia District   Robert E. Davis

412-644-3394x13 

412-644-5496

Atlanta District Thomas D. Clarida 704-344-6116
704-344-6402
Florida District Janneth Caycedo 561-338-5236x23
407-367-8685
New Orleans District Karen Smallwood
Carl Huffman
615-781-5380x144
615-781-5391
San Juan District Jorge Martinez* 787-474-9533
787-729-6747
Chicago District Dennis E. Swartz* 313-393-8156
313-393-8139
Detroit District   Dennis E. Swartz 313-393-8156
313-393-8139
Minneapolis District   Thomas W. Garvin

414-771-7167x12 

414-771-7512

Dallas District John D. Mays
Deborah McGee
Scotty L. Hargrave

214 253-4935

214 253-4935

214 253-4935

Kansas City Reggie Cope 913-752-2403
913-752-2413
Denver District   Robert G. Antonsen  303-236-3025
303-236-3551
Los Angeles District Suzie Kent* 208-334-1054
208-334-1053
San Francisco District Suzie Kent* 208-334-1054
208-334-1053
Seattle District   Suzie Kent* 208-334-1054
208-334-1053

                                                                                                                          

*Providing auditor functions for district


 SAMPLE WARNING LETTER-NONCOMPLIANCE DECLARATION WITH DISTRICT ORDERED ASSEMBLER RECALL LETTER TO X-RAY ASEMBLERS

 

WARNING LETTER

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM'S COMPLETE ADDRESS

 

Dear (Addressee)  : 

Field compliance testing of fully certified diagnostic x-ray systems assembled by (firm name) since  (date) has shown that  (number, e.g., 43)  percent of the x-ray systems tested failed to comply with the Performance Standard for Diagnostic X-ray Systems and Their Major Components (Performance Standard).  Diagnostic x-ray equipment are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).  The Food and Drug Administration (FDA) has issued (number, e.g.,  12) letters to you addressing your firm's noncompliant assemblies, yet you continue to install diagnostic x-ray systems that fail to comply with the Performance Standard.  Based on this high rate of noncompliance with the Performance Standard and your inability to provide assurance that x-ray systems which you assemble will comply with the Performance Standard, the FDA has determined that you fail to comply with Title 21, Code of Federal Regulations (21 CFR), section 1020.30(d).  Therefore, the FDA declares your assemblies since (date) as noncompliant.  As noted below, you are required to provide user notification and corrective action plan (CAP) for the recall of your assemblies. 

You are advised that it is a prohibited act under the Federal Food, Drug, and Cosmetic Act, section 538 of Subchapter C ‑ Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of l968), to fail to correct electronic products that do not comply with an applicable standard, or that have a defect which relates to the safe use of such products.  Additionally, under the Act, it is a prohibited act to adulterate a medical device after receipt in interstate commerce.  Your installations are in violation of 21 U.S.C. 351(c) because they fail to have the quality that they purport or are represented to possess in that they do not comply with the Performance Standard for Diagnostic X-ray Systems and Their Major Components, 21 CFR 1020.30. 

You must respond in writing within 15 working days of receipt of this letter and provide the number of x-ray assemblies you have completed since  (date) .  In responding, you have the following options: 

1. Refutation - You may submit your views and evidence in accordance with 21 CFR 1003.11(a)(3) to establish that the alleged noncompliances do not exist, do not relate to the safety of the product, or are directly attributable to user abuse or lack of maintenance.  Should you choose to refute the allegation of noncompliance, you will have an opportunity to request a hearing under 21 CFR part 16. 

2. Exemption Request - If you do not refute the alleged noncompliance, in accordance with 21 CFR 1003.30, you may request an exemption from the requirements of user and dealer/distributor notification found in 21 CFR 1003.10(b) and from the obligation to correct the violative products found in 21 CFR 1004.1.  You must include the grounds upon which such exemption is requested. Please see 21 CFR 1003.31 for further information on what constitutes reasonable grounds for an exemption. 

3. Purchaser Notification and Corrective Action - If you neither refute the noncompliance nor request an exemption, then you will be required to  (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) to fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost at no charge to the user. 

a. Notification Letter - Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22.  A copy of the notification letter(s) sent to purchasers and dealers must also be sent to this office.  It is recommended that you submit a draft of any letters to us for review and concurrence prior to mailing. Please submit such drafts with your response to this letter, because, under 21 CFR 1003.11(c), you will have only 14 days to furnish the notification to purchasers and dealers/distributors once we direct you to begin notification. 

b. Corrective Action Plan - Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, and 1004.4. Such a plan must expeditiously correct the noncompliance and must be approved by FDA. (See 21 CFR 1004.6) 

If you require additional time to prepare your refutation, notification, CAP, or evidence to support an exemption request, you must submit within 15 working days of the receipt of this letter a written request to this office, which outlines the reasons for any delays and a reasonable target date for submission of your response.  If you do not respond within 15 working days, the agency may consider you to be in violation of section 538(a)(2) and 538(a)(4) of the Act. 

Please be advised that if your refutation or exemption request is not accepted by the FDA, you must submit a CAP for all certified diagnostic x-ray systems you have assembled since  (date) .  An acceptable CAP submission must include: 

1. An agreement to test all assemblies of certified components installed since (date), to ensure that all assemblies comply fully with the Performance Standard. 

2. A statement of the testing to be performed, and a copy of the test method. 

3. An agreement to correct any items of noncompliance detected by the above testing, at no cost to the user.  If you can document that the noncompliance is directly attributed to user abuse or attributable to servicing by another party, you may submit this evidence in lieu of correcting the noncompliance. 

4. A listing of all equipment to be used in the testing and calibration of diagnostic x-ray systems. 

5. An agreement that all equipment that will be used in testing and calibration will be within current calibration.

6. The number of certified systems assembled since (date).

7. A timetable for the correction of all affected systems. 

8. An agreement to submit copies of all test data for FDA review. 

9. A copy of the notification letter to be sent to affected purchasers or a draft of said letter. 

10. Provisions to ensure that all future assemblies of certified diagnostic x-ray systems comply with all aspects of the Performance Standard. 

Failure to promptly correct this violation(s) can result in regulatory action being initiated by the Food and Drug Administration without further notice.  These actions include seizure and/or injunction and/or the imposition of civil penalties as provided for in section 539 of the Act.  Persons violating section 538 of the Act are subject to civil penalties of up to $1,000 per violation and up to a maximum of $300,000. 

You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violation(s), including an explanation of each step taken to prevent the recurrence of similar violations.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.  

Your response should be sent to  (Name) , Compliance Officer, Food and Drug Administration,  (street address) ,  (City, State & zip code) .  If you have any questions,  (name)  can be contacted at  (telephone #).

 

                                                                              Sincerely yours,

 

                                                                              District Director

 

 

Enclosures 


GUIDANCE FOR EVALUATING AN ASSEMBLER RESPONSE TO A NONCOMPLIANCE DECLARATION WITH DISTRICT ORDERED ASSEMBLER RECALL LETTER  

The Federal Food, Drug, and Cosmetic Act (the Act), section 538 of Subchapter C ‑ Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of l968) affords manufacturers the opportunity to respond to a declaration of defect or noncompliance in one of three ways: 

1. Submit evidence to refute the alleged defect or noncompliance.

 2. Submit an exemption request. 

3. Submit a corrective action plan (CAP). 

Generally, noncompliance declarations are prepared with the expectation that the manufacturer will submit a CAP.  However, some manufacturers may choose to first attempt to refute the cited noncompliance, then seek an exemption, and if not successful, submit a CAP; as noted above, these are all available options.  

Evaluating Refutations 

If an assembler can demonstrate that more than one individual noncompliant system was not attributable to improper assembly or calibration, the assembler may have a valid refutation for the declaration of noncompliance.  The statistics involved in identifying assemblers for coverage in this program are such that a shift of one or two violations greatly affects the decision to pursue a District Ordered Assembler Recall (DOAR).  Because of this, we do not include any field tests that are reported to be of manufacturer origin, or are reported as being in dispute. 

The refutation needs to have a sound basis.  The assembler should submit copies of test data and the test method to demonstrate the system fully complied with the Performance Standard at the time of assembly.  Unless such evidence is presented, there is generally no basis for the assembler certification of the respective system. 

If you would like assistance in evaluating a refutation, please contact the Diagnostic Devices Branch (HFZ‑240) at (301) 594-3332. 

Exemption Requests

Exemption requests are permitted by FDA regulations, 21 CFR 1003.30.  The regulations require the manufacturer (assembler) to submit his exemption request in writing, within 15 days of receiving a declaration of defect or noncompliance.  In the case where refutation has been denied, the exemption request must be submitted within 15 days of receiving written denial of the refutation. 

Exemption requests may be granted only if the assembler submits evidence to demonstrate the failure to comply with the Performance Standard does not create a significant risk of injury, including genetic injury, to any person.  Since the capability to evaluate such submission does not exist in most FDA District offices, all exemption requests should be forwarded to the Diagnostic Devices Branch (HFZ‑240) for evaluation.  The Diagnostic Devices Branch will provide the district with their evaluation and a determination as to the acceptability of the exemption request. 

Please note that an assembler who has his exemption request denied may contest the denial in a part 16 hearing (21 CFR part 16).  It is essential therefore, that all exemption requests be submitted to HFZ‑240 for proper evaluation. 

If an exemption is granted, no further action is required.  Since granting an exemption implies no significant hazard to the user, the violative systems cited may not be used for future legal action (civil penalty or injunction) for the same specific violation. 

Please note that the Center does not expect to approve many exemption requests, due to the implied health hazard presented by violative field test results. 

When the Center's evaluation of the exemption request is received in the district, it will contain either a draft denial letter, or draft approval letter.  If the exemption request is denied, the assembler is required to submit a CAP within 15 working days of receiving the denial letter.  The return receipt should be maintained as evidence of receipt by the assembler. 

Corrective Action Plan 

Corrective action plans (CAPs) must include one of the following options: 

1. Repair the noncompliant products.

2. Refund the purchase price of noncompliant product.

3. Replace the noncompliant products with compliant products. 

Of the three options, most assemblers elect to repair the noncompliant components.  Since the other two options do not require explanation, only the repair option will be discussed further. 

The underlying philosophy of declaring as noncompliant all diagnostic x-ray systems installed over certain time period presupposes that combined FDA/State testing has not tested all systems installed by a particular assembler.  This implies that there exist other assemblies (not tested by FDA or the State) of diagnostic x-ray equipment, which also fail to comply.  The purpose of the noncompliance declaration is to obtain a CAP, which will require the testing (and correction) of previously untested system. 

An acceptable CAP will contain the following elements: 

1. The assembler's proposed method of re-testing all assemblies of certified components installed within the specified time period.  (CDRH will help the district with the time frame to be cited in the noncompliance declaration.) 

2. A statement of the testing to be performed and a copy of the test method. 

3. A listing of all equipment to be used in the testing. 

4. Documentation that all equipment used in the testing will be properly calibrated. 

5. The number of certified systems assembled during the period covered by the noncompliance declaration. 

6. A timetable for the correction of all affected systems. 

7. Provisions to submit copies of all test data for FDA view. 

8. A draft notification letter to affected purchasers or a copy of the letter that was sent. 

Assemblers generally will not submit such detailed information in their initial response to the district.  Once a CAP is received, the district should perform a review, and if further guidance is required, contact the Diagnostic Devices Branch (HFZ‑240) at (301) 594-3332.  Since submission of a CAP represents a commitment to correct the violative products, an establishment inspection should be scheduled to collect the recall information. 

During this inspection the investigator may obtain the above commitments regarding the CAP.  If an inspection cannot be conducted in a timely manner, a letter to the assembler requesting the required information may be sent in lieu of an establishment inspection. 

An establishment inspection at this point may check that all items enumerated above can be provided.  The investigator should confirm the following: 

 ‑     The assembler has the test equipment to perform the required testing. 

 ‑     Measurement equipment is properly calibrated. 

 ‑     The adequacy of any test method to be used in compliance testing. 

 ‑     The assembler has maintained records for tracing assemblies of diagnostic x-ray systems. 

 ‑     The assembler has adequate personnel to perform the testing. 

 ‑     The assembler is capable of meeting specified timetables for correction of all systems. 

You should consider granting a 30‑day grace period for submitting the above information.  Assemblers may require this much time to prepare an adequate CAP.  If additional time is required, advise the assembler in writing that he must provide the user notification to affected purchasers within 15 working days of receiving this letter or he will be in violation of The Federal Food, Drug, and Cosmetic Act (the Act), section 538(a)(2) of Subchapter C ‑ Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of l968).

 Please note:  Exemptions usually only apply to products already introduced into commerce, not to future or ongoing installations.  A variance may be requested and granted for an assembler to continue the introduction of products into commerce which do not comply with a part of the Performance Standard in accordance with 21 CFR 1010.4. 


SAMPLE USER NOTIFICATION LETTER FOR DISTRICT ORDERED ASSEMBLER RECALL AND CAPS 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

DOCTOR'S NAME

FIRM NAME

FIRM'S COMPLETE ADDRESS

 

Dear (Addressee)  : 

(Firm name, e.g., ABC X-ray Company) has been advised by the Food and Drug Administration (FDA) that diagnostic x-ray systems assembled by ABC X-ray Company since January 1, 1985, may fail to comply with the Performance Standard for Diagnostic X-ray Systems and Their Major Components (Performance Standard).  The FDA advised that (number, e.g., 43)  percent of the  (number, e.g., 27)  systems they tested failed to comply with the Performance Standard for Diagnostic X-ray Systems and Their Major Components, Title 21, Code of Federal Regulations, Section 1020.30. 

We are working with the FDA to develop a plan for testing all diagnostic x-ray systems we have installed since (date, e.g., June 1, 1985).  Any system we test that fails to comply with the Performance Standard will be adjusted and re-calibrated as necessary to correct the noncompliance.  This will be done at no cost to you, the purchaser/ user. 

Correction of noncompliant diagnostic x-ray systems is a requirement of the Federal Food, Drug, and Cosmetic Act, section 535 of Subchapter C ‑ Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of l968). 

We shall contact you shortly to test your diagnostic x-ray system, and make the necessary adjustments.

 

                                                                              Sincerely,

 

 

                                                                              John Doe

                                                                              ABC X-ray Company


 SAMPLE CAP APPROVAL LETTER TO X-RAY ASSEMBLERS 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

RESPONSIBLE INDIVIDUAL, TITLE

FIRM NAME

FIRM'S COMPLETE ADDRESS

 

Dear (Addressee)

On (date), the FDA sent you a letter advising that between (mo./day/yr.) and (mo./day/yr.), (number, e.g, 43)  percent of your assemblies of certified diagnostic x-ray systems that were tested for compliance with the Performance Standard for Diagnostic X-ray Systems and Their Major Components (Performance Standard) failed to comply.  Of the three options outlined in our letter, you elected to submit a corrective action plan (CAP).  A partial CAP was submitted in your letter of (mo./day/yr.)

On (date), FDA Investigator(s) from this office visited your firm to obtain further information concerning the details of your proposed CAP.  On (date), you submitted additional information which resulted in your CAP submission being complete. 

We understand that you intend to conduct your CAP as follows: 

1.         You will identify all installations of fully certified diagnostic x-ray systems that you assembled between (mo./day/yr.) and (mo./day/yr.)

2.         You will notify all affected purchasers (via certified mail) concerning your CAP. 

3.         You will retest all assemblies of fully certified diagnostic x-ray systems (which have not previously been tested by FDA) reported in 1. to determine if each system is in full compliance with the Performance Standard. 

4.         You will correct all items of noncompliance which you encounter during your retests.  You will also notify this FDA office of each of the noncompliances you encounter.
 

5. __________________________________________________________________.

 

6. __________________________________________________________________.

 

We are approving your CAP contingent upon the following: 

1. You will submit monthly status reports which include: (1) the number of systems to be corrected, (2) the number of purchaser notification letters sent, (3) the number of letters returned as undeliverable, (4) the number of systems tested, (5) the number of systems which were noncompliant, and (6) the number of noncompliant systems which were corrected, including details of each noncompliance 

Purchaser notification will be made in accordance with all requirements of 21 CFR 1003.21.  This office is to be included in the notification process as if it were a purchaser.                                                                

 

2. ___________________________________________________________________ . 

You may commence implementation of your CAP upon receipt of this letter. 

Please note that the ABC X-ray Company is responsible for the correction of all certified x-ray systems that you have assembled between (mo./day/yr.) and (mo./day/yr.).  Should your CAP prove ineffective, we reserve the right to require you to take more stringent measures. 

The Food and Drug Administration classifies corrective action plans for diagnostic x-ray products as recalls.  We will notify you of the classification of this recall and the FDA recall number.  When making monthly reports or in any future correspondence relating to this CAP, please reference the recall number.  Monthly status reports should be sent to: 

(Name)

Recall and Emergency Coordinator, HFR‑     

Food and Drug Administration

(Street address)

(City, State and zip code)

 

Please be advised that it is FDA policy to report facts surrounding all noncompliances with the Performance Standard in the FDA Enforcement Report.  This publication is available to the public. 

If you have any questions concerning this matter, please contact (name) at (address), (telephone number).

 

                                                            Sincerely yours,

 

 

                                                            District Director