Medical Devices

Inspection and Field Testing of Radiation-Emitting Electronic Products

Program 7386.001

CHAPTER 86 MEDICAL AND RADIOLOGICAL DEVICE MONITORING AND QUALITY CONFORMANCE

PRODUCT CODES	PRODUCT/ASSIGNMENT CODES
SUBJECT: Inspection and Field Testing of Radiation-Emitting Electronic Products		IMPLEMENTATION DATE 10/31/2007
		COMPLETION DATE 9/30/2010
DATA REPORTING
95RH-XXX (See Attachment B for detail)	86001
95RH-XXX (See Attachment C for detail)	86002
94RH-XXX (See Attachment D for detail)	86004

This compliance program consolidates and supersedes the following compliance programs:

7386.001 – Inspection of Manufacturers of Laser Products
7386.002 – Field Implementation of the Sunlamp and Sunlamp Products Performance Standard As Amended
7386.004 – Field Compliance Testing of Cabinet X-Ray Equipment

FIELD REPORTING REQUIREMENTS

Submit all Establishment Inspection Reports (EIRs) and field test reports, attachments, exhibits, correspondence between the district and firm, and other documentation to:

Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
ATTN: Electronic Products Branch
10903 New Hampshire Avenue

Silver Spring, MD 20993

Copies of the EIRs and field test reports, attachments, exhibits, correspondence between the district and firm and other documentation should be routed to appropriate Radiological Health staff, as identified in Part VI of this program, to the accomplishing district and to the district where the firm is located (if located in a different district from the accomplishing district).

All FACTS and PODS data should be entered by the accomplishing district where the operation was performed.

This document represents the agency’s current thinking on the enforcement of the Federal Food Drug and Cosmetic Act Electronic Product Radiation Control provisions and related regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

PART I - BACKGROUND

This compliance program provides guidance to FDA field and center staff for the inspection, field test and administrative/enforcement activities related to the Electronic Product Radiation Control (EPRC) provisions of the Federal Food Drug and Cosmetic Act (FFDCA, the Act) and regulations contained in Title 21 of the Code of Federal Regulations, Parts 1000 – 1050 (21 CFR 1000 – 1050). The intent of these requirements is to protect the public from unnecessary exposure to electronic products radiation. Manufacturers are responsible for producing products that do not emit hazardous or unnecessary radiation and that comply with all applicable radiation safety performance standards. All electronic product manufacturers must comply with applicable requirements in Title 21 CFR 1000, 1002, 1003, 1004 and 1005. If a mandatory radiation safety performance standard applies to a manufacturer’s product, then the manufacturer must also comply with Title 21 CFR 1010 and the product must comply with the requirements of the specific standard found in 21 CFR 1020 – 1050. Manufacturers are required to self-certify their own products to be compliant with an applicable standard, based on a quality control testing program as described in 21 CFR 1010.2. The purpose of EPRC inspections and field tests are to verify that products comply with performance standards, and that the manufacturer’s quality control testing program ensures such product compliance and radiation safety.

This program applies to certain electronic products subject to radiation safety performance standards described in 21 CFR 1010 – 1040, including:

21 CFR 1020.10 Television Receivers
21 CFR 1020.40 Cabinet X-Ray Systems
21 CFR 1030.10 Microwave Ovens
21 CFR 1040.10 Lasers and Laser Systems
21 CFR 1040.11 Specific Purpose Laser Products
21 CFR 1040.20 Sunlamps and Sunlamp Products

Diagnostic x-ray inspection and testing is conducted under Compliance Program 7386.001. Products and manufacturers subject to standards contained in 21 CFR 1020 – 1050, but are not listed above, will be subject to inspection or test on a for-cause basis only at the direction of CDRH.

The body of this program contains basic instructions for inspection, field test and administrative/enforcement activities applicable to all electronic products. Inspection and field test checklists, and additional considerations and instructions for specific products, such as laser, sunlamp, cabinet x-ray, television and microwave oven products, are covered in ATTACHMENTS B - F.

Medical devices that emit electronic product radiation are subject to EPRC requirements as well as Medical Device provisions of the Act and related regulations. Medical device inspection and enforcement activities described in Compliance Program 7382.845, Inspection of Medical Device Manufacturers, may be conducted jointly with this program at CDRH and district discretion. Examples of radiation-emitting medical devices include medical laser and sunlamp products, which could be covered by a joint EPRC/medical device inspection.

PART II – PROGRAM/IMPLEMENTATION

A. OBJECTIVES

This is a continuing, non-statistical compliance program intended:

To evaluate an electronic product manufacturer’s quality control testing program for its ability to ensure such product compliance and radiation safety.
To identify certified electronic products which fail to comply with the requirements of applicable performance standards
To obtain correction of deficient quality control testing programs and noncompliant products identified by initiating appropriate administrative/regulatory action.
To provide guidance to manufacturers regarding compliance with the laws and regulations administered by FDA.

B. PROGRAM MANAGEMENT INSTRUCTIONS

1. Planning Instructions

The role of the individual investigator and field radiological health specialists is a critical factor for the effective implementation of this program. Field specialists such as Electro-Optics Specialists (EOS) and Regional Radiological Health Representatives have been specifically trained in general EPRC requirements and may have specialized training in one or more performance standards.

Only individuals trained in EPRC requirements should perform these inspections and field tests. Contact CDRH/OCER Electronic Products Branch (HFZ-240) and DFI (HFC-130) should the need for expertise, not otherwise available in the District, become apparent. At the discretion of CDRH and the district, radiological health specialists may be used to accompany a medical device investigator to conduct joint EPRC/medical device inspections. If an individual has training in both EPRC and medical device inspections, a single individual may conduct both portions of the inspection.
Field radiological health specialists, their particular area of expertise, physical location and primary geographical areas of responsibility are listed in Part VI of this program.
Based on the resources in the current FY workplan, field radiological health specialists will develop assignments for their organization. The assignments will be reviewed by his or her supervisor, entered into FACTS and transmitted to the affected field staff, Districts, HFC-l32 and HFZ-240. Workplans should include district inspections, field tests, and known CDRH assignments. The establishment inventory and guidance from CDRH should be used to determine inspection and field test locations.

2. Pre-announcement of Inspections

Pre-announcement of EPRC inspections conducted under this compliance program is not mandatory, although it is recommended to facilitate the inspection. Pre-announcement ensures the firm is producing electronic products for the US market on the day of inspection, gives the firm time to collect all necessary procedures and records, and ensures appropriate individuals are available during the inspection. Section 537 of the Act permits inspection of any manufacturer for good cause, grounds for which may include introduction of any noncompliant product into US commerce, failure to comply with EPRC reporting requirements, or for purposes of suspected problems with a manufacturer’s quality control testing program and product conformance with performance standards.

Inspections of radiation-emitting medical device manufacturers must be pre-announced if the inspection will cover medical device Quality Systems Regulation compliance. Refer to instructions provided in the Guide to Inspections of Quality Systems, August 1999, and IOM Section 5.2.1.1, Pre-Announcements.

3. Pre-announcement of Field Tests

Schedule an appointment with the user prior to the field test. Tell the user that the purpose of the visit is to conduct a survey of an electronic product to determine compliance with FDA’s Federal radiation safety performance standards.

Request that persons familiar with the operation of the electronic product to be tested be available to assist in the operation of the equipment.

4. Inspections and Field Test Priorities

Inspections and field testing of electronic product manufacturers should be prioritized using the following criteria:

Manufacturers and products posing a potential risk to public health or with great public health impact. High-risk products may be identified by additional product-specific guidance provided in Attachments B – F, direction provided from CDRH, level of radiation emissions accessible to the public or volume of products on the US market.
Manufacturers or products with known compliance problems discovered through field testing, report review, complaints or other reason.
New manufacturers that have not yet been inspected
Products incorporating technology new to the US market or a major change in existing product.

5. Resource Instructions

Field personnel may require personal radiation monitors, such as thermal luminescent dosimeter badges, when performing tests under this program. Dosimeters must be worn when performing inspections of cabinet x-ray manufacturers, cabinet x-ray field tests, and other products that can emit x radiation. These monitors are available from the Winchester Engineering and Analytical Center (WEAC) Radiation Safety Officer. Part VI of this program contains the current list of contacts for WEAC.
Field personnel are responsible for contacting OCER and OSEL to arrange to have their radiation measurement equipment re-calibrated annually. Any personnel that do not have the appropriate radiation meters may request that equipment be loaned by another district or by CDRH, if available.

CDRH will be phasing out calibration services currently provided for a number of instruments in the field, and alternate sources of equipment maintenance and calibration services will be identified. CDRH will assist in identifying sources for these services, and will maintain an inventory of equipment that may be available for use by field staff on loan.

PART III INSPECTIONAL

A. OPERATIONS

1. Inspectional Strategy

The purpose of electronic product manufacturer inspections is to evaluate the firm’s quality control testing program to ensure product compliance with applicable performance standards and radiation safety. The inspection should also verify that EPRC requirements for reporting and recordkeeping are met by the firm.

2. Electronic Product Radiation Control Inspection

Items to cover
1. The firm’s product(s) comply with the applicable requirements of the standard to the extent that:
  - The product has the applicable performance features, labels, and instructions for operation, maintenance and service
  - The product emissions are properly characterized. If appropriate, request to make measurements during the inspection using available FDA or manufacturer instruments to confirm emission specifications are below any established limits. Otherwise, witness the measurements performed by the manufacturer to confirm.
  - The brochures, catalogs and other promotional material contain any required warnings or label reproductions
2. The firm has procedures and documents for control of the manufacturing process appropriate to the product type and production volume including:
  - Stock and inventory control
  - Bills of materials
  - Control drawings and procedures that are authenticated and current
  - Incoming inspection, criteria for acceptance/rejection, and segregation of accepted from rejected parts
  - Disposition of rejected parts
  - Finished goods storage and inventory
3. The firm has quality control testing procedures and records to cover:
  - In-production tests to verify product compliance during production
  - Final test and inspection of finished products
  - Maintenance and calibration of test equipment
4. The firm maintains records required by the electronic product radiation control regulations:
  - Distribution to first purchasers or distributors
  - Safety related complaints, inquiries
  - Real or alleged injuries
  - Remedial actions taken for reports of non-compliant products, complaints, injuries
  - Reports submitted to CDRH
Specific product inspection and field test checklists or forms, if available, are included in ATTACHMENTS B – F. These checklists should be used in conjunction with the above guidance to record inspection and test observations.
Records to collect
1. Organization chart identifying key individuals responsible for product design, manufacturing and quality control
2. Copies of testing procedures and where possible photographic evidence showing that testing does not ensure product safety or compliance with applicable standards
3. Samples of violative labels
4. Copies of manuals, in part or whole, that fail to contain required materials
5. Copies of brochures and catalogs that fail to contain required warning or label reproductions
6. Distribution records for any violative products
Foreign inspections

All foreign inspections should be conducted using this guide, and any special instructions contained in the inspection assignment. The failure of any foreign manufacturer to comply with these requirements may result in detention upon entry.

Foreign inspections are subject to scheduling and time constraints as several manufacturers will be inspected in a single trip. Early planning is critical to conducting foreign inspections. Firms inspected must be notified as early as possible to ensure the firm will be producing for the US on the day of inspection, to give the firm time to collect all necessary procedures and records, prepare translations of needed documents, and make arrangements to have a translator available if needed.

Any investigator with appropriate training may conduct foreign EPRC or joint EPRC/medical device inspections. For example, field specialists such as Electro Optics Specialists (EOS) and Regional Radiological Health Representatives have been trained in general EPRC requirements and may have specialized training in one or more performance standards.
Medical Device Inspections
Radiation-emitting medical devices are subject to both electronic product radiation control requirements and medical device requirements including the Quality System, Medical Device Reporting (MDR), Medical device Tracking, Corrections and Removal, and Registration and Listing regulations.

Based on district concurrence, a joint EPRC/medical device inspection covering the firm’s compliance with both sets of requirements may be conducted under this compliance program and Compliance Program 7382.845 for Inspection of Medical Device Manufacturers.
- The EPRC portion of the inspection should follow the instructions provided specifically in this program to determine the firm’s compliance with electronic product radiation control requirements for reporting and recordkeeping, certification to applicable performance standards, and a quality control testing program that ensures product compliance and radiation safety. Report EPRC time under the appropriate PAC identified in this program.
- The medical device portion of the inspection should follow instructions provided in the medical device inspection compliance program to assess the firm’s quality system. Manufacturers of devices subject to radiation safety performance standards contained in 21 CFR Parts 1020 – 1050 should include in their device master and history records those procedures and records demonstrating compliance with the applicable standard, self-certification (21 CFR 1010), and reporting (21CFR 1002 – 1005). Report medical device time under the appropriate medical device PAC identified in Compliance Program 7382.845.
For-Cause Directed inspections
For-cause inspections are conducted in response to specific information that raises questions, concerns, or problems associated with the electronic product. Information can come from a variety of sources including:
- Sample analysis results
- Prior inspectional observations
- Questionable information in product reports
- Reports of injuries related to the firm’s products
- Consumer or trade complaints about the firm.
For cause inspections are usually initiated at the request of CDRH. For-cause inspections will generally follow instructions provided in this compliance program, with additional questions and issues to cover provided in the assignment.
Inspectional Observations Review
Review inspectional observations with the most responsible individual and other technical experts at the firm prior to concluding the inspection. Record EPRC observations on the Form FDA-483. This compliance program provides guidance concerning severity of violations observed to identify major deficiencies. Deficiencies should be noted on Form FDA-483 in order of descending importance (i.e. most serious first). If both EPRC and medical device observations are noted, they should be grouped separately on the form.

The district has discretion to offer annotation of the FDA 483 for an EPRC inspection, if the investigator and firm believe annotation will facilitate the inspection process. An offer to annotate the FDA 483 should be extended for all joint EPRC/medical device inspections. When a FDA 483 is annotated, it should be done in accordance with the IOM Chapter 5 (Section 5.2.3).

The following statement should be included on each FDA 483:

“This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective actions in response to an observation, you may discuss the objection or action with FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above."

For all medical device inspections the FDA 483 should contain the following additional statement:

“The observations noted in this form FDA 483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self audits to identify and correct any and all violations of the quality system requirements.”

3. Electronic Product Radiation Control Field Tests

Field tests are examinations of installed electronic products and may be conducted at trade shows, manufacturing facilities or other sites where products are in use. Field tests assess the individual product’s compliance with applicable performance standard requirements alone. It can not be expected that there will be staff on site with expert knowledge of the product being field tested or that it will be possible to evaluate all aspects of product compliance.

Items to cover:
1. Product emissions are properly characterized. If possible, confirm by direct measurement using FDA or available instrumentation on-site documenting all maintenance and calibration information. At a minimum, document claimed product emissions based on product labeling review.
2. Product incorporates required performance features
3. Product displays the labels with required contents
If the product becomes damaged during a field test, the owner, investigator, and supervisor should complete the appropriate sections of the form FDA 2766 entitled, Claim for Damages to an Electronic Product. Instructions for completion are on the back of the form, which is available from the FDA Forms Catalog (see FDA intranet home page under “forms” section).
Records to collect:
1. Purchase information documenting the manufacturer and distributor of the product
2. Supporting documents or photographic evidence for questionable items, including noncompliant user and service manuals, inadequate protective housing, lack of interlocks, or lack of required labeling
3. Copy of promotional literature to show product specifications and intended use
4. Samples of violative labels
5. Copies of manuals (or manual sections) that fail to contain required materials
Field test observations review
Review field test observations with the most responsible individual at the location and with other appropriate staff after completing the field test. Deficiencies should be noted in order of descending importance (i.e. most serious first) on the field test record form. If a field test is conducted as part of an inspection, field test results should be noted on the FDA-483 along with inspectional observations.

Share observations by providing a copy of the FDA- 483 and/or field test checklist or form.

Indicate that FDA will follow up with the manufacturer and take action to correct deficiencies, as appropriate. In the event of a Class A hazard, recommend the product should not be used until corrected. This compliance program provides guidance concerning severity of violations observed to identify major deficiencies in ATTACHMENTS A – F.

4. Investigations:

Investigations are to be made to determine whether a suspected firm is in fact a manufacturer of one or more electronic products. The investigation may be initiated in preparation for a possible inspection, as a result of trade complaints, or from discovery via the Internet or printed materials of promotion of products that may not comply with EPRC requirements.

5. Physical and Documentary Samples:

Physical samples of products are generally not collected under this compliance program. Samples are not required to support a letter issued to the firm or further action to include program disapproval or legal action. However, samples can be useful to support inspectional observations to demonstrate inadequacy of the quality control testing program or product noncompliance. The investigator should consult district management and CDRH to determine whether collecting physical samples would support any subsequent letter or action initiated. Documentary samples may be collected when collecting an actual physical sample is not practical and the evidence is necessary to support inspectional observations.

Collect samples according to procedures defined in the Investigations Operations Manual, Chapter 4, and coordinate any sample collection activity with CDRH and WEAC to ensure proper procedures are followed and chain of custody is observed to maintain sample integrity.

PART IV ANALYTICAL

No laboratory testing will be done under this program. CDRH or WEAC testing may be required on special assignments under Compliance Program for Lab Testing CP 7386.006 or as indicated in Part III.A.5 of this program.

PART V REGULATORY/ADMINISTRATIVE FOLLOW UP

A. REGULATORY PHILOSOPHY AND STRATEGY

CDRH is generally responsible for the final review of inspections and field tests made under this program and for the issuance of letters resulting from inspections and field tests performed by field radiological health staff. Exceptions where the district has direct reference authority are noted below under section C, Regulatory Action. The intent of this program is to follow up on problems that pose a radiation safety hazard or are a flagrant violation of EPRC requirements.

Violations of EPRC requirements may include:

Failure to comply with an applicable performance standard
Failure to establish and conduct an adequate quality control testing program
Failure to submit required reports, including initial, model change, annual or accidental radiation occurrence reports

Appropriate regulatory or administrative actions include issuance of a notification of defect or non-compliance letter (warning or untitled letter), requiring repurchase, repair or replacement of product under an approved corrective action plan, or imposition of civil penalties and/or injunction. Appropriate follow-up actions should be determined by CDRH or in consultation with CDRH to ensure consistency in how EPRC requirements are enforced.

CDRH has classified several potential items of non-compliance that might be observed during an inspection or field test and classified those items in terms of health hazard and regulatory action. Tables are provided in Attachments A – F to provide guidance for use during the inspection or field test, while preparing FDA-483 and EIR or field test reports, and in classifying the inspection or field test and recommending follow-up.

B. DISTRICT RESPONSIBILITIES

1. Reporting inspection and test findings

Inspection reports
Provide a copy of the completed inspection and test record used during the inspection along with the Establishment Inspection Report (EIR) and exhibits. Refer to the IOM for EIR formats, and clearly indicate the scope of the inspection in the EIR. Document any corrections performed during the inspection or corrections promised with the timeframe for completion.
Field test reports
Provide a copy of the completed field test record along with a summary of findings.

2. Recommending Action

A table of violations and their health and safety risk as well as the nature of the regulatory response has been provided for each product area.

Hazard Class for Non-Compliance
Class A, B, C, and D refer to the hazard class of the observations, related to the severity of the threat to health and safety posed by a particular non-compliant product or practice.
- Class A: Conditions that pose an immediate radiation hazard to health and safety. Notify CDRH/OCER contacts identified in Part VI of this program immediately to discuss appropriate action to stop production or product use until corrective action has been taken. Consider contacting State Health Department or other local contacts to assist in addressing problems with product use, if warranted.
- Class B: Conditions that include radiation safety defects or items of noncompliance with the standard which, without corrective action, could pose a radiation hazard if the non-compliance or defect is not addressed.
- Class C: Labeling or user information fails to comply with a standard.
- Class D: No problems found.
Regulatory Response to Non-Compliance
The designations of a violation as Major, Minor, or Concern refer to the level of regulatory response required to correct deficiencies.
- Major: Non-compliance with a standard that always warrants regulatory action such as a warning letter.
- Minor: Non-compliance with a standard about which a manufacturer should be informed but is not severe enough to warrant a warning letter.
- Concern: Non-compliance which is not severe enough to mention unless also informing a manufacturer about a Major or Minor item.
Inspection Classification
Based on inspectional findings, the district will classify the inspection as OAI, VAI or NAI for further action.

If any major EPRC deficiencies exist, the district is expected to classify the inspection as OAI and recommend further regulatory action. Examples of findings that would result in an OAI classification include:
- Total failure to establish a quality control testing program capable of ensuring radiation safety of the product or compliance with applicable performance standards.
- Any single observation of a major deficiency listed in the specific product non-compliance tables contained in Attachments A – F of this program
- Several observations consisting of minor deficiencies listed in Attachments A – F of this program

The inspection may be classified VAI for a limited number of minor deficiencies listed in Attachments A – F and further regulatory action will be pursued at the discretion of the district and CDRH.

If it is determined that the EPRC deficiencies are of a quantity and type to conclude there is minimal probability that the firm will produce unsafe or noncompliant products, the inspection will be classified NAI and Form FDA-483 will serve to inform the firm of any objectionable findings. Deficiencies identified as violations of concern will generally not require additional follow-up but should be discussed with the firm.

Consult CDRH if additional guidance is required to classify inspection and test observations. If the inspection also covered firm compliance with medical device Quality Systems requirements, Compliance Program 7382.845, Part V, Quality System/GMP Regulatory/Administrative Follow-Up, should be consulted for appropriate regulatory and administrative follow-up.

C. REGULATORY ACTION

In determining appropriate regulatory action based on inspection and test findings, the district and CDRH should consider the significance of the product, the firm’s history, whether the problem is widespread and continuing. Actions which may be considered include notification of noncompliance letters (warning and untitled letters), product repurchase, repair or replacement (recall), civil penalties and injunctions, and seizures (for radiation-emitting medical devices).

1. Notification of noncompliance letters (Warning and Untitled Letters)

The Electronic Product Radiation Control provisions of the Federal Food Drug and Cosmetic Act (Section 535) and related regulations (21 CFR 1003) require the Agency to notify manufacturers in writing when product noncompliance with a standard is found. Manufacturers may also be advised in writing of a failure to comply with reporting and recordkeeping requirements (21 CFR 1002.31). A table classifying the severity of items of noncompliance with reporting and recordkeeping, and performance standard requirements is included in Attachments A – F.

Issuance of all letters should follow Chapter 4 of the Regulatory Procedures Manual (RPM). Consult the Office of Enforcement’s (OE) Warning Letter page on ORA’s intranet for current instructions for obtaining Office of Chief Counsel (OCC) clearance and for current approved Warning Letter templates. Letter templates must be used to satisfy Agency notification requirements in 21 CFR 1003.11. Where approved OCC templates are not available, consult CDRH for the current version of letter templates.

Districts have DIRECT REFERENCE AUTHORITY for EPRC letters in certain areas which are described in Chapter 4 of the RPM. For example, districts have direct reference authority to issue sunlamp product warning and untitled letters, to grant exemption from notification, and approve manufacturer corrective action plans, which are further described in Attachment C of this program. CDRH is available for consult in assessing product noncompliance or developing regulatory and enforcement strategy.

For the majority of cases, where districts DO NOT have direct reference authority to issue EPRC letters, forward the report with exhibits and recommended action to CDRH for review and follow-up. CDRH will copy the accomplishing district on any letters issued and consult on regulatory and enforcement strategy when needed.

Major Notification of Noncompliance Letter (Warning Letter)
This letter notifies the firm of major items of noncompliance and requires the firm to further notify purchasers and recall products. The firm is required to address all items in the letter, and submit a corrective action plan for CDRH approval.

Issue a major notification (warning) letter when the violation of the standard requires further regulatory action.
- All major violations must be addressed in a warning letter.
- Firms and products with several minor violations may also be issued a major notification letter, depending on the public health significance of the violation(s) and the number of products involved.
- Violations of concern may also be included in a major notification (warning) letter, but would not warrant issuance of a major notification (warning) letter on their own merit.
The firm’s quality control testing program may be also be disapproved upon issuance of a major notification letter, when the Agency believes that the manufacturer’s quality control and testing program is not following good manufacturing practices. A program disapproval orders the manufacturer to cease certification of products (i.e. stop production and testing) until the program disapproval is rescinded, and places the firm’s products on automatic import detention without prior examination, under authority of Section 534(h) of the Act and 21 CFR1010.2 of the regulations. A program disapproval may be issued only by CDRH.
Minor Notification of Noncompliance Letter (Untitled Letter)
This letter notifies the firm of minor items of noncompliance and exempts the firm from further notifying purchasers and recalling products. The firm is instructed to address all items in the letter and make appropriate corrections for future production.

Issue a minor notification (untitled) letter when the violation of the standard does not justify further regulatory action at the time.
- Firms and products with a limited number of minor violations may be issued a minor notification letter, depending on the public health significance of the violation(s) and the number of products involved.
- Violations of concern may also be included in an untitled letter, but would not warrant issuance of an untitled letter on their own merit.

2. Repurchase, Repair, or Replacement of Electronic Products (Recall)

The Electronic Product Radiation Control provisions of the Federal Food Drug and Cosmetic Act (Section 535) and related regulations (21 CFR 1004) also provide for manufacturer repurchase, repair or replacement of the noncompliant electronic products.

Every major notification of noncompliance letter issued as a result of a major violation or several minor violations requires manufacturer repurchase, repair or replacement of the affected electronic products at no cost to the purchaser. The firm is required to address all items in the letter, and submit a corrective action plan for CDRH approval. Refer to RPM Chapter 7, Attachment E for approval of manufacturer's corrective action plans.

3. Refutation or Exemption from Notification or Correction Requests

Manufacturers can refute the noncompliance or be granted an exemption, by making a written request to CDRH. The exemption can be granted upon request by the manufacturer or by the Agency at its own initiative, and must show that the noncompliance does not create a significant risk of injury.

Within 15 days after notification of the noncompliance/defect by FDA, a manufacturer may refute the alleged noncompliance under 21 CFR 1003.11(a)(3) or request an exemption from purchaser notification and correction as specified under 21 CFR 1003.30. If a manufacturer refutes the alleged noncompliance, or requests an exemption, the evidence presented by the manufacturer is evaluated by CDRH before granting or denying the request for exemption or responding to the refutation. Refer to RPM Chapter 7, Attachment E for information on responding to exemption requests and refutations.

4. Timeframes for action

Immediately notify CDRH and State and local health authorities (through RRHR) for any Class A hazard.

For all inspections and tests that may require issuance of a letter, the EIR should be provided to CDRH or the district compliance officer to allow sufficient time to review, draft, and secure approval for the letter. Timeframes for clearance of letters are provided in Chapter 4 of the RPM.

5. Civil Penalties/Injunctions

Civil penalties should be recommended for violations of Subchapter C of the Act after other actions have failed to achieve compliance, or for knowing and willful violations. More severe civil penalty assessments may be sought under Section 303(f). See CPG Sec. 390.300 and RPM Chapter 6, Civil Penalties - Electronic Product Radiation Control. Informal consultation with the Center at an early stage in the development of a regulatory action is encouraged in order to facilitate timely implementation of the action; contact Electronic Products Branch Chief or Lead CSO at 301-796-5710.

If an establishment has a continuing pattern of significant deviations in spite of past warnings, injunction will usually be the recommended action of choice. If a serious health hazard exists, the recommendation should include a request for a temporary restraining order (TRO) to prevent the distribution of products that have been manufactured under the violative conditions documented by the inspection report per the instructions in Chapter 6 of the RPM. Civil penalties and injunctions may be recommended concurrently.

6. Detention/Seizure

Use administrative detention and recommend seizure of a defective or noncompliant radiation-emitting medical device if all three conditions below apply:

There is a Class A health hazard
The owner/operator refuses to remove the product from service or returns the product to use before the Class A hazard is corrected
The EPRC provisions are ineffective in achieving timely correction by the manufacturer

Informal consultation with the Center at an early stage in the development of a regulatory action is encouraged; contact Electronic Products Branch Chief or Lead CSO at 401-796-5710.

D. FEDERAL/STATE RELATIONS

Some states have Radiation Control Programs within the State Health Department or Department of Environmental Health, which may have adopted portions of the EPRC requirements into their radiation safety regulations.

Districts should use all reasonable means available to encourage voluntary conformance of products with the performance standard regardless of the date of manufacture. It is recommended that the districts coordinate regulatory activity with appropriate state representatives through the RRHR and DFSR, particularly where local authority may assist in achieving correction of a deficiency. This may be particularly useful to address issues related to product use where the State may have regulatory authority, which extends beyond FDA authority to regulate the design, production or manufacture of the product.

E. MEDICAL DEVICE REGULATORY/ADMINISTRATIVE FOLLOW-UP

Regulatory follow-up for joint EPRC/quality systems inspections can be handled separately or in combination at the discretion of the district and CDRH. Refer to Part V in Compliance Program 7382.845, Quality System/GMP Regulatory/Administrative Follow-Up, for guidance on regulatory actions related to radiation-emitting medical devices. Enforcement actions on radiation emitting medical device firms, which also include EPRC violations, require CDRH concurrence before implementation by the field. Contact CDRH for consultation when both EPRC and quality systems violations are noted during an inspection or field test.

PART VI REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS

A. REFERENCES

1. Law

Federal Food, Drug, and Cosmetic Act, As Amended
Electronic Product Radiation Control Provisions (formerly known as the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, 0ctober 18, 1968)

2. Regulations

21 CFR 1000 – 1005, General Requirements for All Electronic Products which Emit Radiation
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1000&CFRPartTo=1005

21 CFR 1010, Performance Standards for Electronic Products: General
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1010

21 CFR 1020 – 1050, Specific Performance Standards for Electronic Products
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1020&CFRPartTo=1050

3. Regulatory Procedures Manual (RPM)

4. Investigations Operations Manual (IOM) - Chapter 5

5. FDA Web Sites

FDA home page

ORA home page

CDRH home page

Field Accomplishments and Compliance Tracking System (FACTS)
(visit ORA’s home page, then click the FACTS icon.)

Electronic Product Radiation Control home page

Product Code Classification Database (searchable)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/pcdsimplesearch.cfm

CDRH Good Guidance Practices Page (searchable)

B. ATTACHMENTS

C. PROGRAM CONTACTS

Center for Devices and Radiological Health

Office of Communication, Education and Radiation Programs, Division of Mammography Quality and Radiation Programs (DMQRP)

Contact for support in planning and executing inspections and field tests, classification of items of non-compliance, and for interpretation and current policy on EPRC requirements. Send all inspection and test reports to Chief, Electronic Products Branch, FDA/CDRH Office of Communication, Education and Radiation Programs (HFZ-240), 1350 Piccard Drive, Rockville, MD 20850.

Name	Phone	Email	Mail Stop	Position/Expertise
Robert Doyle	301-796-5863	robertj.doyle@fda.hhs.gov	HFZ-240	Chief, Electronic Products Branch
Dr. Helen Barr	301-796-5713	helen.barr@fda.hhs.gov	HFZ-240	Director, DMQRP
Thomas Ohlhaber	301-796-5712	thomas.ohlhaber@fda.hhs.gov	HFZ-240	Deputy Director, DMQRP
Rosa Brown	301-796-5896	rosa.brown@fda.hhs.gov	HFZ-240	Program Analyst
Daniel Hewett	301-796-5864	daniel.hewett@fda.hhs.gov	HFZ-240	Consumer Safety Officer, laser products
Dan Kassiday	301-796-5865	daniel.kassiday@fda.hhs.gov	HFZ-240	Engineer, cabinet, industrial, analytical, security x-ray products
George Kraus	301-796- 5866	george.kraus@fda.hhs.gov	HFZ-240	Consumer Safety Officer, TV and microwave oven products, imports
L. Dale Smith	301-796-5868	l.smith@fda.hhs.gov	HFZ-240	Consumer Safety Officer, laser light show products
Cory Tylka	301-796-5869	corinne.tylka@fda.hhs.gov	HFZ-240	Consumer Safety Officer, medical laser products
Varsha Savalia	301-796-5867	varsha.savalia@fda.hhs.gov	HFZ-240	Consumer Safety Officer, sunlamp and UV and laser products

Office of Science and Engineering Laboratories

Contact for assistance with identifying appropriate instrumentation for use in measuring electronic product radiation emissions.

Name	Phone	Email	Mail Stop	Position
Robert Faaland	(301) 827-4683	robert.faaland@fda.hhs.gov	HFZ-130	Engineer, laser expert
Sharon Miller	(301) 827-4692	sharona.miller@fda.hhs.gov	HFZ-130	Engineer, UV expert
Mary Walker	(301) 796-2558	mary.walker@fda.hhs.gov	TBD	X-ray instrumentation and calibration

Office of Regulatory Affairs

Field Regional Radiological Health Representatives

Name	Phone	Email	Mail Stop	Position
Mike Leal	(508) 793-0422	michael.leal@fda.hhs.gov	HFR-NE2570	NE RRHR
Karen Smallwood	(615) 366-7823	karen.smallwood@fda.hhs.gov	HFR-SE350	SE RRHR
Rachel Evans	(312) 596-6518	rachel.evans@fda.hhs.gov	HFR-CE25	CE RRHR
Scotty Hargrave	(214) 253-4930	scotty.hargrave@fda.hhs.gov	HFR-SW19	SW RRHR
Terri Jones	(503) 671-9711 x36	terri.jones@fda.hhs.gov	HFR-PA3515	PA RRHR

Field Electro-Optics Specialists and laser product contacts

Name	Phone	Email	Mail Stop	Position
Emir Galevi	(781) 729-5700 x724	emir.galevi@fda.hhs.gov	HFR-NE480	Engineer, WEAC
Leo Lagrotte	(813) 228-2671 x35	leo.lagrotte@fda.hhs.gov	HFR-SE2585	Electro-Optics Specialist, SER
James E. Frye	(513) 684-2700 x149	james.frye@fda.hhs.gov	HFR-CE400	Electro-Optics Specialist, CER
Don Leeseberg	(210) 541-9450	don.leeseberg@fda.hhs.gov	HFR-SW1545	Consumer Safety Officer, SWR
Gary L. Zahaek	(408) 291-7548 x103	gary.zaharek@fda.hhs.gov	HFR-PA1530	Electro-Optics Specialist, PAR
Frank J. Eng	(408) 291-7548 x105	frank.eng@fda.hhs.gov	HFR-PA1530	Electro-Optics Specialist, PAR

Winchester Engineering and Analytical Center contacts

Name	Phone	Email	Mail Stop	Position
John Marzilli	(781) 729-5700 x749	john.marzilli@fda.hhs.gov	HFR-NE400	WEAC Director
Jim Cherniak	(781) 729-5700	james.cherniack@fda.hhs.gov	HFR-NE400	Radiation Safety Officer
Vacant	Vacant	Vacant	HFR-NE400	Engineering Branch Director, WEAC
Jane Driscoll	(781) 729-5700 x716	jane.driscoll@fda.hhs.gov	HFR-NE480	Metrology Supervisor
Joe Matrisciano	(781) 729-5700 x736	joseph.matrisciano@fda.hhs.gov	HFR-NE480	Engineering Supervisor

Headquarters contacts

Name	Phone	Email	Mail Stop	Position
Mei-Ying Li	(301) 827-2913	meiying.li@fda.hhs.gov	HFC-150	ORO, DFSR