[Federal Register Volume 63, Number 221 (Tuesday, November 17, 1998)]
[Notices]
[Pages 63933-63935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30608]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0946]


Expansion of Medical Device Industry Initiatives

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) initiated a pilot 
program in 1996 involving the medical device industry. This pilot 
program, which was formally adopted in 1997, was shown to optimize 
resource utilization, enhance FDA/industry communication, and provide 
firms prompt closure to corrected inspection observations and 
nonviolative inspections. This program includes eligibility criteria 
and procedures for preannounced inspections, the annotation of items on 
form FDA-483-List of Observations (FDA-483) with promised or completed 
corrections, and postinspection notification to establishments 
regarding their compliance status.

DATES: The pilot program is effective January 1, 1999. Written comments 
should be submitted by January 4, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Denise D. Dion, Office of Regulatory 
Affairs (HFC-130), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-5645, FAX 301-443-6919.

SUPPLEMENTARY INFORMATION: During the FDA/medical device industry 
grassroots forums in 1995, several issues were discussed concerning 
FDA's interaction with the medical device industry. A decision was made 
to consider action on three of the issues discussed. These included 
instituting: (1) Preannounced inspections, (2) listing promised or 
completed corrective actions on FDA-483 items, and (3) postinspection 
notification to establishments regarding their compliance status.
    After considering these issues, the agency decided to initiate a 
pilot program involving the medical device industry in fiscal year (FY) 
1996. The pilot program occurred during the 1996 calendar year and was 
then formally evaluated. The pilot program included criteria and 
procedures for preannounced inspections, the annotation of FDA-483 
items with promised or completed corrections, and postinspection 
correspondence.
    The program was restricted to inspections of medical device 
manufacturers that manufactured only medical device products, and it 
did not include manufacturers of products that cross different program 
areas like devices/drugs/biologics.

[[Page 63934]]

    Although the pilot program did not include those inspections 
performed under State contract for FDA, the contracts were modified 
after permanent adoption of the Medical Device Initiatives.
    Implementation of the program was not shown to decrease the level 
of necessary enforcement. Previous FDA experience had indicated that 
the overall out-of-compliance rate for preannounced foreign inspections 
was comparable to, or even greater than, the overall out-of-compliance 
rate for domestic inspections where preannouncements generally were not 
made.
    Preannounced inspections were offered to those medical device firms 
that met the criteria for inclusion in the pilot program. FDA-483 
annotations and the postinspection notification were done for all 
medical device inspections. The annotations and the notifications were 
independent of whether the inspection was preannounced.
    The purpose of the pilot program was to optimize resource 
utilization, enhance FDA/industry communication, and provide firms 
prompt closure to corrected inspection observations and nonviolative 
inspections, and inspections in which voluntary action only is 
indicated.
    There were 1,034 domestic medical device inspections (excluding 
bioresearch monitoring inspections) conducted during the pilot program. 
FDA received 432 completed industry feedback questionnaires and summary 
questionnaire data from FDA investigators for all 1,034.
    The investigators' questionnaire data showed that 844 (or 81 
percent) of the inspections were preannounced (the others were either 
not eligible for preannouncement or were begun prior to April 3, 1996, 
the start of the pilot program). Of those that were preannounced, 69 
percent had inspection time savings due to preannouncement. 
Investigators reported that 83 percent of those preannounced 
inspections were facilitated by the preannouncement for the following 
reasons: Inspections had quicker startups; inspections had records more 
readily available; and inspections had personnel more readily 
available.
    Investigators reported that 443 FDA-483's, Inspection Observations, 
were issued during this pilot program. The investigators reported that 
during 83 percent of the inspections, they were notified by the firm of 
corrections made during the inspection. Investigators reported that 
during 78 percent of the inspections, the time spent to annotate the 
FDA-483's was worthwhile.
    Of the 1,034 inspections conducted under this pilot program, 893 
(or 89 percent) of the inspections were classified ``no action 
indicated'' (NAI) or ``voluntary action indicated'' (VAI). Seven-
hundred sixty-nine (or 86 percent of the 893 NAI/VAI inspections) 
postinspection letters were issued by the end of the pilot program 
period, December 31, 1997. Due to a time lag between conclusion of the 
inspection and issuance of the letters, additional letters were sent 
but not reported as part of the pilot evaluation.
    The industry's questionnaire data indicated that in 90 percent of 
the inspections that were preannounced, the preannouncements were 
helpful to the firms in preparing for the inspection. Industry 
responded that during 93 percent of the inspections, the firm's 
personnel were notified during the inspection of noncompliances found 
by the inspection team and that in 86 percent of the inspections, the 
firms notified the FDA inspection team of corrective actions. In 78 
percent of the inspections, the FDA inspection team was able to verify 
that corrective actions had been made.
    The industry respondents reported that 95 percent of them felt that 
the FDA-483 annotations were appropriate and 94 percent felt that they 
were helpful. Ninety-five percent of the respondents found the 
postinspection letters helpful and 95 percent of the respondents felt 
the pilot program helped to increase the spirit of cooperation between 
their establishment and FDA.
    Twenty-one of the investigator responses stated that the 
preannouncements compromised the inspection process. Further evaluation 
of these 21 responses revealed that 19 of the respondents had 
misunderstood and thus inaccurately answered this question. The 
remaining two have been evaluated and FDA has concluded that the 
problems described by these investigators do not warrant discontinuing 
the program. Because of the positive findings of the evaluation, the 
program was formally adopted as the Medical Device Initiatives program 
in FY 1997. The elements of the Medical Device Industry Initiatives 
Program are described in Attachment A of a new inspection guide 
entitled ``Guide to Inspections of Medical Device Manufacturers,'' 
dated December 1997 and posted to FDA's World Wide Website at 
``www.fda.gov/ora''.
    With some industry-specific caveats, FDA is prepared to begin 
another yearlong pilot program of the initiatives to provide similar 
coverage to the other program areas, including drugs (both human and 
animal) and biologics. Only FDA-483 annotation and postinspection 
notification will be piloted in the foods program area. Upon completion 
of the pilot program, FDA will perform an evaluation to evaluate the 
effectiveness in optimizing resources, enhancing FDA/industry 
communication, and providing firms prompt closure to corrected 
inspection observations and nonviolative inspections, or inspections in 
which voluntary action only is indicated. In addition, the impact on 
violative situations will be evaluated.
    The elements of the agency initiatives are as follows:

I. Preannounced Inspections

A. Basic Premises

    1. Preannouncement of inspections is intended to be applied only 
to those drug, medical device and biologics, except for blood and 
plasma collection and processing firms, that meet the criteria for 
consideration. Preannouncement of inspections is not applicable for 
manufacturers of or other operators dealing in only food, blood or 
plasma product commodities.
    2. The eligibility of an individual firm for preannounced 
inspection is at the discretion of the inspecting 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 the 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 be 
later than 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 the preannouncement portion of the 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 inspecting office to determine 
whether it is appropriate to preannounce a planned inspection will 
include:

1. Type of Inspection:

    a. Premarket inspections (PMA, NDA, prelicense, etc.),
    b. Foreign inspections,
    c. Bioresearch monitoring inspections,
    d. Quality system (QS) or good manufacturing practice (GMP) 
inspections:
     Biennial routine inspections,

[[Page 63935]]

    Initial inspections of newly registered establishments,
    Initial inspections of new facilities, and
    Initial inspections under new management and/or ownership.
    e. Non-QS/GMP inspections other than:
    Government Wide Quality Assurance (GWQAP) inspections with short 
deadlines,
    Immediate and urgent responses to complaints,
    Immediate and urgent followup to information from any source, 
and
    Immediate hazard to health recall followup inspections.
    f. Recall followup inspections at manufacturers/initial 
importers/U.S. designated agent.

2. Eligibility Criteria:

    a. 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 inspection.

C. Procedures

    1. The investigator or coordination group designated to conduct 
the inspection will contact or, if unavailable at the time of 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 or coordinating group for a team inspection) 
informing the firm of an upcoming inspection. Usually it will be 
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 inspections in all program areas, the investigator will 
annotate the FDA-483 at the time of issuance to acknowledge an 
establishment's promised or completed corrective action. The firm 
should review the annotations on this issued FDA-483 to ensure that 
there are no misunderstandings about promised corrective actions.
    2. A reportable item will not be deleted from the 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 the 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 the FDA-483 is issued. This discussion will include those 
observations that may be written on the FDA-483 and 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. Investigators are encouraged to 
verify the establishment's completed corrective actions 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 the FDA-483 should be annotated 
(either following each observation or at the end of the FDA-483) 
with one or more of the following comments, as appropriate:
    Item # ______ reported corrected but not verified.
    Item # ______ corrected and verified.
    Correction of items______, ______ and promised by 00/00/98.
    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 Compliance Achievement Reporting 
Systems (CARS).

III. Postinspection Notification

A. Basic Premise

    1. FDA will issue postinspection notification to establishments 
regarding their compliance status for all inspections except foreign 
drug establishments. Foreign drug establishments have traditionally 
and will continue to receive correspondence from FDA upon evaluation 
and closure of each inspection.
    2. The two new categories under which firms will receive 
postinspection notification are:
    a. NAI situations where no FDA-483 was issued or only limited, 
less significant deficiencies were reported.
    b. VAI situations where an FDA-483 was issued but all profile 
classes were found acceptable. In this circumstance, no further 
action is contemplated based on the inspection.
    3. The postinspection notification letters that are issued under 
this pilot program will be mailed under the signature of the 
district director, in that district in which the establishment is 
located, or the Director of the Center of Compliance, as 
appropriate.
    4. For those inspections where further action is being 
considered, FDA's existing modes of notification will continue to be 
used.

    Dated: November 5, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-30608 Filed 11-16-98; 8:45 am]
BILLING CODE 4160-01-F