[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Notices]
[Pages 14786-14789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8185]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0086]
Medical Device Industry Initiatives
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: FDA is initiating a pilot program in 1996 involving the
medical device industry. This pilot program is intended to optimize
resource utilization, enhance FDA/industry communication, and provide
firms prompt closure to corrected inspectional observations and
nonviolative inspections. This pilot program includes eligibility
criteria and procedures for preannounced inspections, the annotation of
items on form FDA-483-List of Inspectional Observations (FDA 483) with
promised or completed corrections, and postinspectional notification to
establishments regarding their compliance status.
[[Page 14787]]
EFFECTIVE DATE: April 1, 1996.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: James L. Dunnie, Office of Regulatory
Affairs (HFC-132), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-3340, fax 301-827-0929.
SUPPLEMENTARY INFORMATION:
Background
During the recent FDA/medical device industry grassroots forums,
several issues were discussed concerning FDA's interaction with the
medical device industry. A decision was made to take 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) postinspectional notification to establishments
regarding their compliance status.
After considering these issues, the agency decided to initiate a
pilot program in fiscal year 1996 involving the medical device
industry. This pilot program will occur during the 1996 calendar year
and then be formally evaluated. The pilot program will include criteria
and procedures for preannounced inspections, the annotation of FDA-483
items with promised or completed corrections, and postinspectional
correspondence.
This initiative is currently restricted to inspections of medical
device manufacturers that manufacture only medical device products, and
not to those products that may cross different program areas like
devices/drugs. This initiative may be expanded in the future to other
areas after evaluation of the pilot program.
FDA currently maintains contracts with the States of California,
Colorado, and Texas to conduct medical device inspections on behalf of
FDA. This pilot program will not include those inspections done under
State contract for FDA. Noncontract medical device inspections,
however, done by FDA personnel in these States, will be eligible for
this pilot program.
The purpose of the pilot program is to optimize resource
utilization, enhance FDA/industry communication, and provide firms
prompt closure to corrected inspectional observations and nonviolative
inspections, and inspections in which voluntary action only is
indicated.
Implementation of the pilot 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 generally are not made.
This pilot program for preannounced inspections will not affect any
of the other current 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 pilot program. FDA-
483 annotations and the postinspectional notification will be done for
all medical device inspections during the period of this pilot. The
annotations and the notifications are independent of whether the
inspection has been preannounced.
The elements of the pilot program are as follows:
I. Preannounced Inspections
A. Basic Premises
1. This pilot 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
pilot 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. Medical device bioresearch monitoring inspections,
d. Good manufacturing practice (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.
e. NonGMP inspections other than:
Immediate and urgent responses to complaints,-
Immediate and urgent followup to informant information,
and-
Immediate hazard to health recall followup inspections.
f. Recall followup inspections at medical device manufacturers/
initial importers (under new regulations, the 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 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 will be appropriate to inform the firm
as to the purpose, estimated duration, and the
[[Page 14788]]
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.
D. Criteria for Assessing the Success of the Preannounced Inspections
1. Office of Regional Operations (ORO) will provide a questionnaire
to be completed by district personnel for each of the inspections made
under this pilot program. The districts will be responsible for
tracking the responses to each of the questionnaires. An end of the
calendar year survey of the districts will be conducted by the Division
of Emergency and Investigational Operations (DEIO)/Investigations
Branch.
2. Industry groups and involved firms will have an opportunity to
provide their opinions and recommendations for improvement after FDA
has had some experience with the pilot program, through such possible
mechanisms as a customer satisfaction survey.
3. CDRH will be asked to provide comments.
4. Comments received in response to this notice will be considered.
II. FDA-483 Annotations
A. Basic Premise
1. In this pilot program for all medical device establishments, the
investigator will annotate 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.
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 # ________ reported corrected but not verified.
Item # ________ corrected and verified.
Correction of items ________, ________ and ________ promised by 00/
00/96.
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 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).
C. Criteria for Assessing the Success of FDA-483 Annotations
1. ORO will provide a questionnaire to be completed by district
personnel for each of the inspections made under this pilot program.
The districts will be responsible for tracking the responses to each of
the questionnaires. An end of the calendar year survey of the districts
will be conducted by the DEIO/Investigations Branch.
2. Industry groups and involved firms will have an opportunity to
provide their opinions and recommendations for improvement after FDA
has had some experience with the pilot program, through such possible
mechanisms as a customer satisfaction survey.
3. CDRH will be asked to provide comments.
4. Comments received in response to this notice will be considered.
III. Postinspectional Notification
A. Basic Premise
1. During this pilot program FDA will issue additional
postinspectional notification to establishments regarding their
compliance status.
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 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 pilot program will be mailed under the signature of the district
director, in that district in which the establishment is located.
4. For those inspectional followups where regulatory action is
being considered, FDA's existing modes of notification will continue to
be used.
B. Criteria for Assessing the Success of Postinspectional Notification
1. ORO will provide a questionnaire to be completed by district
personnel for each of the inspections made under this pilot program.
The districts will be responsible for tracking the responses to each of
the questionnaires. An end of the calendar year survey of the districts
will be conducted by the DEIO/Investigations Branch.
2. Industry groups and involved firms will have an opportunity to
provide their opinions and recommendations for improvement after FDA
has had some experience with the pilot program, through such possible
mechanisms as a customer satisfaction survey.
3. CDRH will be asked to provide comments.
4. Comments received in response to this notice will be considered.
[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)
[[Page 14789]]
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 good manufacturing practices (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
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
followup 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 followup 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 good manufacturing practices (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
GMP's.
For further information, please contact the following individual at
this office:
(name and telephone number)
Sincerely,
Enclosures: FDA-483
Interested persons may, on or before June 3, 1996, submit comments
to the Dockets Management Branch (address above). Two copies are to be
submitted, except that individuals may submit one copy. Comments are to
be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Dockets Management
Branch (address above) between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: March 25, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8185 Filed 3-29-96; 4:05 pm]
BILLING CODE 4160-01-F