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Page 25

 

Guide to Inspections of Medical Device Manufacturers 

 

 December 1997 

 

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_________________________________________________________________

 

ATTACHMENT A-MEDICAL DEVICE INDUSTRY INITIATIVE  

 

The following guidance/procedures should be followed. 
Background 

 

In 1996, FDA initiated a pilot program involving the medical device industry to enhance FDA/industry communication, optimize resource utilization, and provide firms with prompt closure to corrected inspectional observations and nonviolative inspections. The pilot program, now known as the Medical Device Industry Initiatives program (MDII), includes eligibility criteria and procedures for preannounced inspections, the annotation of items on form FDA-483, Inspectional Observations, with promised or completed corrections and postinspectional notification to establishments regarding their compliance status. 
 
The MDII program is currently restricted to inspections of medical device firms that manufacture only medical device products, and not to those who manufacture products that may cross different program areas like devices/drugs. 

 

 FDA currently maintains contracts with the States of California, Colorado, and Texas to conduct medical device inspections on behalf of FDA. This program will include those inspections done under State contract for FDA. 

 

This program will not impact on violative situations because there will not be a decreased level of enforcement, if enforcement is necessary. Previous FDA experience indicates that the overall out-of-compliance rate for preannounced foreign inspections is comparable or even greater than the overall out-of-compliance rate for domestic inspections where preannouncements were not generally made prior to implementation of the MDII program. 

 

Preannounced inspections will not affect any other FDA programs that may involve prior inspectional notification. 

 

Preannounced inspections will be offered to those medical device firms that meet the criteria for inclusion in the program. FDA-483 annotations and the postinspectional notification will be done for all medical device inspections. The annotations and the notifications are independent of whether the inspection was preannounced. 

 

The elements of the MDII program are as follows: 

 

I. Preannounced Inspections 
A. Basic Premise 

 

1. This program is intended to be applied only to those medical device manufacturers that meet the criteria for consideration. 

 

2. The eligibility of an individual firm for participation in this program is at the discretion of the district office using clearly described criteria. (See section I.B. of this document). 

 

3. The implementation of this preannounced inspection program is intended to be flexible, based on appropriate considerations of the agency and firm. 

 

4. The preannouncement should generally be no less than 5 calendar days in advance of the inspection. Should a postponement be necessary, the decision as to the time of rescheduling rests with the investigator/team, but the new inspection date should not exceed 5 calendar days from the originally set date. Inspections may be conducted sooner than 5 calendar days if requested by the firm and if this date is acceptable to the investigator/team. 

 

5. To participate in this program, firms are expected to meet the commitment to have appropriate records and personnel available during the inspection. 

 

6. Preannounced inspections will not limit an investigator's authority to conduct the inspection. Inspections will be as in depth as necessary. 

 

B. Criteria for Consideration 

 

The criteria to be used by the district office to determine whether it is appropriate to preannounce a planned inspection will include: 

 

1. Type of Inspection: 

 

a. Premarket inspections (PMA and 510(k)), 
b. Foreign inspections, 
c. Quality System/Good Manufacturing Practice (QS/GMP) inspections of medical device establishments: 

 

* Biennial routine inspections, 
*Initial inspections of newly registered establishments, 
*Initial inspections of new facilities, 
*Initial inspections under new management and/or ownership. 

 

d. Non QS/GMP inspections other than: 

 

* Immediate and urgent responses to complaints, 
* Immediate and urgent follow-up to informant information, and 
* Immediate hazard to health recall follow-up inspections. 

 

e. Recall follow-up inspections at medical device manufacturers/ initial importers (under new regulations, the U.S. designated agent). 

 

(Bioresearch monitoring (BIMO) inspections are done per Compliance Programs 7348.808, 7348.808A, 7348.809, 7348.810 and 7384.811. Procedures described in those programs for preannouncements will be followed). 

 

2. Eligibility Criteria: 

a. QS/GMP inspections of firms with nonviolative histories (inspections classified as no action indicated (NAI) or voluntary action indicated (VAI)). 

 

For VAI, adequate corrections of conditions observed and listed on FDA-483 during the previous inspection were verified and did not lead to any further agency action. 

 

b. To remain eligible for preannounced inspections, firms must have a history of having individuals and/or documents identified in previous preannounced inspections reasonably available at the time of the inspection. 

 

C. Procedures 

 

1. The investigator designated to conduct the inspection will contact or, if unavailable at the time of the call, leave word for the most responsible individual at the facility. 

 

2. Changes in dates should be kept to a minimum. If a change is made, a new date should be provided as soon as possible that will facilitate the inspection and accommodate the investigator's schedule. 

 

3. Preannouncements are normally limited to the investigator (or lead investigator for a team inspection) informing the firm of an upcoming inspection. Usually it is appropriate to inform the firm as to the purpose, estimated duration, and the number of agency personnel expected to take part in the inspection. The products or processes to be covered should also be described if this will facilitate and be consistent with the objectives of the inspection. 

 

4. When known, specific records/personnel will be requested at the time the inspection is scheduled. 

 

II. FDA-483 Annotations 

 

A. Basic Premise 

 

1. For all medical device establishments, the investigator will annotate the FDA-483 at the time of issuance to acknowledge an establishment's promised or completed corrective action. Industry should review the annotations on this issued FDA-483 to ensure that there are no misunderstandings on promised corrective actions. (BIMO inspections are excepted from the annotations portion of this program.) 

 

2. A reportable item will not be deleted from FDA-483 because the establishment has promised or completed a corrective action. The investigator will continue to have the latitude to delete the observation if the establishment's response to the observation clearly shows that the observation is in error or to clarify the observation based on additional information provided. 

 

3. FDA investigators will continue to report only significant observations on FDA-483 and to discuss these and other less significant observations with the establishment's management. 

 

B. Procedures 

 

1. Investigators and analysts will discuss all observations with the management of the establishment as they are observed, or on a daily basis, to minimize surprises, errors, and misunderstandings when FDA-483 is issued. 
This discussion will include those observations that are potentially written FDA-483 items or oral observations. Industry should use this opportunity to ask questions about the observations, request clarification, and inform the inspection team what corrections have been or will be made as soon as possible during the inspection process. Investigators are encouraged to verify the establishment's completed corrective action as long as the verification does not unreasonably extend the duration of the inspection. 

 

2. Where practical, FDA-483 observations should include the number of records of a given type examined, for example, ``Two out of 50 records examined were * * *.'' 

 

3. If the establishment has promised and/or completed a corrective action to an FDA-483 observation prior to the completion of the inspection, all copies of FDA-483 should be annotated (either following each observation or at the end of FDA-483) with one or more of the following comments, as appropriate: 

 

- Item # XXXX reported corrected but not verified. 
- Item # XXXX corrected and verified. 
- Correction of items XXXX, XXXX and XXXX promised by 00/00/96. 
- Item #XXXX, no comment at this time. 

 

4. If an observation made during a prior inspection is noted as not being corrected or is a reoccurring observation, it is appropriate to note this on the FDA-483. 

 

5. All corrective action taken by the establishment and verified by FDA should be discussed in detail in the establishment inspection report and reported using the Corrective Action Reporting Systems (CARS). 

 

III. Postinspectional Notification 

 

A. Basic Premise 
1. As part of this program FDA will issue additional postinspectional notification to establishments regarding their compliance status within 30-45 days of the inspection. 

 

2. The two categories under which firms will receive postinspection notification are: 

 

 a. NAI situations where no FDA-483 was issued or only limited, less significant violations were reported. 
  b. VAI situations where an FDA-483 was issued but all profile classes were found acceptable. In this circumstance, no regulatory action is contemplated based on the inspection. 

 

3. The postinspectional notification letters that are issued under this program will be mailed under the signature of the district director, in that district in which the establishment is located. For international inspections, they will be issued under the signature of the Director, Division of Program Operations, CDRH. 

 

4. For those inspectional follow-ups where regulatory action is being considered, FDA's existing modes of notification will continue to be used. 
(BIMO postinspectional correspondence will be issued as appropriate by CDRH/Office of Compliance, Division of Bioresearch Monitoring.) 

 

[The following is an example of a letter intended to be issued in situations classified as NAI where no FDA-483 was issued, or only limited less significant violations were reported:] 

 

Date: 

 

Name: 

 

Address: 

 

Dear: 

 

The Food and Drug Administration (FDA) conducted an inspection of your firm's (description) facility at (address) on (date). The inspection covered the products described below. 
(list of products and their profile classes) 

 

The areas inspected appear to be in substantial compliance with the applicable requirements of the Federal Food, Drug, and Cosmetic Act and implementing regulations. 

 

Based on these findings, the agency is prepared to endorse applicable pending premarket (PMA) submissions or export certificates for products manufactured at your facility that were specifically inspected. This information is available to Federal agencies when they consider awarding contracts. There may be other products and operations of your firm for which the conclusions from this inspection are not applicable. The agency may separately inspect your firm's facilities to address quality system/good manufacturing practices (QS/GMP's) in these areas. 

 

Your firm has an ongoing responsibility to conduct internal self-audits, to ensure you are continuing to maintain conformance with QS/GMP's. 
For further information, please contact the following individual at this office: 
(name and telephone number) 

 

Sincerely, 
 
 
[The following is an example of a letter intended to be used in situations classified as VAI where an FDA-483 was issued, but all profile classes were found to be acceptable. This type of letter should be issued only when no regulatory action is contemplated, including issuing a warning letter:] 

 

Date: 

 

Name: 

 

Address: 

 

Dear: 

 

The Food and Drug Administration (FDA) conducted an inspection of your firm's (description) facility at (address) on (date). The inspection covered the products described below. 
(list of products and their profile classes) 

 

While some adverse practices/conditions were observed during the inspection,they do not appear to warrant consideration of regulatory follow-up at this time. These problems were reported to you on an FDA-483 (copy enclosed) issued at the conclusion of the inspection. The problems should be corrected and we encourage you to advise us as to your follow-up actions. 

 

Based on these findings, the agency is prepared to endorse applicable pending premarket (PMA) submissions or Export Certificates for products manufactured at your facility that were specifically inspected. This information is available to Federal agencies when they consider awarding contracts. There may be other products and operations of your firm for which the conclusions from this inspection are not applicable. The agency may separately inspect your firm's facilities to address quality system/good manufacturing practices (QS/GMP's) in these areas. 

 

Your firm has an ongoing responsibility to conduct internal self-audits, to ensure you are continuing to maintain conformance with QS/GMP's. 

 

For further information, please contact the following individual at this office: 
(name and telephone number) 

 

Sincerely, 

 

Enclosures: FDA-483 

 

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