[Federal Register Volume 64, Number 44 (Monday, March 8, 1999)]
[Notices]
[Pages 11018-11023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5523]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0645]
Medical Device Warning Letter Pilot
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is initiating a pilot
program involving the medical device industry that is a continuation of
the ``medical device industry initiatives.'' This pilot concerns the
issuance of warning letters for quality system, premarket notification
submission (510(k)), and labeling violations. This pilot is intended to
optimize resource utilization, enhance communication between industry
and FDA, and provide firms with incentives to promptly correct
violations or deficiencies. The pilot includes eligibility criteria and
procedures for the issuance of warning letters.
EFFECTIVE DATES: Initiation date March 29, 1999. Termination date
September 8, 2000.
ADDRESSES: Submit written comments on the pilot to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with
the docket number found in brackets in the heading of this document.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
pilot.
FOR FURTHER INFORMATION CONTACT:
Device quality system warning letter pilot: Jeffrey B. Governale,
Division of Compliance Policy (HFC-230), Office of Regulatory Affairs,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-0411, FAX 301-827-0482.
Premarket notification (510(k)) and labeling warning letter pilot:
Chester T. Reynolds, Office of Compliance (HFZ-300), Center for Devices
and Radiological Health, Food and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 301-594-4618, FAX 301-594-4610.
SUPPLEMENTARY INFORMATION:
I. Background
During FDA/medical device industry grassroots forums, several
issues were discussed concerning FDA's interaction with the medical
device industry. After considering these issues, the agency is
initiating a pilot program that will last
[[Page 11019]]
for 18 months, and then be formally evaluated. The pilot includes
procedures for the issuance of warning letters for quality system (21
CFR part 820), 510(k) (21 CFR part 807, subpart E) and labeling (e.g.,
21 CFR part 800, subpart B; part 801, and part 809, subparts B and C)
violations. This pilot is currently restricted to the medical device
industry and is a continuation of the medical device industry
initiatives.
The purpose of this pilot is to optimize resource utilization,
enhance communication between the medical device industry and FDA, and
provide firms with incentives to promptly correct violations or
deficiencies. Implementation of this pilot will not impact on violative
situations where enforcement action is necessary to protect the public
health.
The agency has adopted good guidance practices (GGP's) that set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). In the Federal Register of August 27, 1998 (63 FR 45821), FDA
published a notice of availability of the draft pilot as a Level 1
guidance document consistent with GGP's. FDA received comments on the
draft from a medical device trade association and three individual
firms. FDA evaluated these comments and made revisions to the guidance
as appropriate.
The medical device warning letter pilot is being issued as a
guidance document and represents the agency's current thinking on the
subject. 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 applicable statute,
regulations, or both. The pilot consists of two parts that are
described below:
I. Device Quality System Warning Letter Pilot
Effective Dates: Initiation date March 29, 1999. Termination
date September 8, 2000.
This pilot is restricted to the medical device industry and is
a continuation of the medical device industry initiatives.
Following a domestic device quality system inspection which
finds current good manufacturing practice (CGMP) deficiencies
(situation 1, compliance program (CP) 7382.830-part V) that warrant
a warning letter, the establishment is to be given 15 working days
to respond from the issuance date of the list of inspectional
observations (FDA-483). If the firm's written response to the FDA-
483 is deemed to be satisfactory by the district office, then a
warning letter should not be issued.
The device quality system warning letter pilot does not apply
to:
1. Nonquality system inspections such as mammography,
radiological health, and bioresearch inspections;
2. Establishments that manufacture devices as well as other FDA
regulated products;
3. Establishments that manufacture devices that are regulated
by the Center for Biologics Evaluation and Research (CBER);
4. Recidivous establishments as defined in CP 7382.830;
5. Any inspection that uncovers CGMP, premarket notification
submission (510(k)), or labeling deficiencies that may cause serious
adverse health consequences;\1\
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\1\ ``Serious adverse health consequences'' are to have the same
meaning as ``serious injury,'' which is defined in Sec. 803.3(aa)(1)
(21 CFR 803.3(aa)(1)).
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6. A compliance followup inspection when the previous
inspection resulted in a warning letter or regulatory action for
quality system, 510(k), or labeling violations;
7. Any inspection that discloses other significant device
violations (e.g. medical device reporting or premarket approval) in
addition to quality system, 510(k), or labeling violations which
warrant the issuance of a warning letter or regulatory action; or
8. A situation where the firm's management failed to make
promptly available to FDA personnel all requested information and
records required by regulations or laws enforced by FDA.
If the district is essentially satisfied with the written
response to the FDA-483 but needs further clarification, it may seek
additional information via untitled correspondence, meetings, or
telephone.
If the firm fails to respond to the FDA-483, a warning letter
should be sent to the establishment once the 15 working day period
has expired.
If the district receives a response to the FDA-483 within 15
working days, the district has 15 working days from the receipt date
to determine whether the response is satisfactory.
If it is necessary for the district to consult with the Center
for Devices and Radiological Health's Office of Compliance for
technical assistance, the latter office has 15 working days to
respond to the district and then the district has 15 working days,
following receipt of the Center's response, to respond to the
establishment. In this situation, the agency should not exceed 30
working days from the receipt date of the written response to the
FDA-483.
If the written response to the FDA-483 is determined to be
unsatisfactory, the district should send a warning letter to the
establishment.
When no warning letter is issued by the district office due to
the firm's satisfactory written response, the postinspectional
notification letter (see attachment 1 of this document) should be
sent to the establishment. The inspection should be classified as
voluntary action indicated (VAI) and the profile should be
designated as acceptable.
When no warning letter is issued, following a satisfactory
written response, and the next inspection discloses situation 1 CGMP
deficiencies, then FDA personnel should proceed as if a warning
letter had been issued for the previous inspection and consider
appropriate enforcement action. (See the graphic for the device
quality system warning letter pilot as attachment 2 and table 1 for
attachment 3.)
This pilot will be evaluated by FDA at the end of the 18-month
period.
Copies of all domestic warning letters that include a device
CGMP adulteration charge (section 501(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351(h))) for inspections that are
initiated between March 29, 1999, and September 8, 2000, should be
forwarded by the districts to the Division of Compliance Management
and Operations (DCMO)/Office of Enforcement (OE) (HFC-210) with a
cover page. (See attachment 4 for a copy of this cover page.)
When warning letters are not issued for situation 1 CGMP
deficiencies under this pilot, copies of the postinspectional
notification letters issued for the inspections initiated between
the above dates should be sent to Jeffrey B. Governale, Division of
Compliance Policy (DCP)/OE (HFC-230) by the districts.
Any questions concerning this pilot should be directed to
Jeffrey B. Governale via telephone (301-827-0411), facsimile (301-
827-0482), or electronic mail (Jeffrey Governale@OE@FDAORAHQ).
Attachments, as stated:
Attachment 1--Model Postinspectional Notification Letter for Device
Quality System Warning Letter Pilot
[Name and title of most responsible individual]
[Establishment's name and 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 following devices:
[list devices and their profile classes]
At the end of the inspection, the FDA investigator left a list
of inspectional observations (FDA-483) at your firm. We have
received your firm's written response, dated [date] to that FDA-483.
Copies of this response and the FDA-483 are enclosed.
While this inspection found deficiencies of your quality system
that would warrant a warning letter if not corrected, your written
response has satisfied us that you either have taken or are taking
appropriate corrective actions. At this time, FDA does not intend to
take further action based on these inspectional findings. The agency
is relying on your commitment regarding corrective actions and,
should we later observe that the deviations from the quality system
regulation have not been remedied, future regulatory action (e.g.,
seizure, injunction and civil penalties) may be taken without
further notice.
Based upon your corrective action, the deficiencies noted
during FDA's inspection will not affect applicable pending premarket
submissions or export certificates for devices manufactured at your
facility that were specifically inspected. This information is
available to Federal agencies when they consider awarding contracts.
There may be other devices and operations of your firm for
which the conclusions from
[[Page 11020]]
this inspection are not applicable. The agency may separately
inspect your firm's facilities to address the quality system
regulation in these areas.
Your firm has an ongoing responsibility to conduct internal
self-audits to assure you are continuing to maintain conformance
with the quality system regulation.
For further information, please contact the following
individual at this office:
[name and telephone number]
Sincerely,
District Director
______________ District Office
Enclosures
bcc:
HFC-230 (Governale)
[district office internal distribution]
BILLING CODE 4160-01-F
[[Page 11021]]
[GRAPHIC] [TIFF OMITTED] TN08MR99.022
BILLING CODE 4160-01-C
[[Page 11022]]
Attachment 3--Device Quality System Warning Letter Pilot
Important: If one or more of your answers to any of the
questions are different than those found in the answer column of
Table 1, then this pilot does not apply to your situation. You
should follow FDA's normal standard operating procedures instead.
Table 1
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Number Question Answer
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1............ In addition to devices, does the establishment No
manufacture other FDA regulated products?
2............ Does the establishment manufacture devices that are No
regulated by CBER?
3............ Is the establishment a recidivous firm per CP 7382.830? No
4............ Did the inspection uncover CGMP, 510(k), or labeling No
deficiencies that may cause serious adverse health
consequences?
5............ Was this a compliance followup inspection to a warning No
letter or regulatory action for quality system, 510(k),
or labeling violations?
6............ Did the inspection disclose other significant device No
violations in addition to quality system, 510(k), or
labeling violations which warrant the issuance of a
warning letter or regulatory action?
7............ Did the firm's management make promptly available to FDA Yes
all required information that was requested?
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Attachment 4--Cover Page for the Device Quality System Warning Letter
Pilot
To: FDA/ORA/OE/DCMO (HFC-210)
(mailing address: 5600 Fishers Lane, Rockville, MD 20857-001)
From: ____________________
________District (HFR-______)
Establishment's name and address:
Date inspection was initiated:
(This cover page should be attached to each warning letter that
includes a device CGMP adulteration charge (under section 501(h) of
the act). Please refer to the device quality system warning letter
pilot before filling out this cover page.)
The attached warning letter was issued for device CGMP
deficiencies. Please check all of the following statements that
apply:
______ The establishment did not respond to the FDA-483 within
15 working days.
______ The establishment provided an unsatisfactory response
to the FDA-483 within 15 working days.
______ The establishment manufactures devices as well as other
FDA regulated products.
______ The establishment manufactures devices that are
regulated by CBER.
______ The inspection uncovered CGMP, 510(k), or labeling
deficiencies that may cause serious adverse health consequences.
______ The inspection disclosed other significant device
violations (e.g., medical device reporting or premarket approval) in
addition to quality system, 510(k), or labeling violations which
warrant the issuance of a warning letter or regulatory action.
______ The firm's management failed to make promptly available
to FDA personnel all requested information and records required by
regulations or laws enforced by FDA.
Please record any comments that the district may have
concerning this pilot on the back of this cover page.
II. Premarket Notification (510(k)) and Labeling Warning Letter Pilot
Effective Dates: Initiation date March 29, 1999. Termination
date September 8, 2000.
A. Background
The impetus for this pilot has its origins in FDA grassroots
meetings with the medical device industry. During these meetings,
warning letters, for both premarket notification submission (510(k))
and labeling violations, were identified as topics for discussion.
Manufacturers contend that:
1. They are often unaware of the agency's concerns about 510(k)
and labeling issues until they receive a warning letter;
2. Information about these concerns is often available at the
time of the inspection; and
3. If notified during the inspection, manufacturers would have
an opportunity to respond, and perhaps resolve, the concerns
identified by the investigators.
Consequently, this pilot has been developed in response to the
device industry's concerns. The purpose of this pilot is to
determine whether notifying firms about 510(k) and labeling issues,
in lieu of a warning letter, will result in the efficient resolution
of the issues.
B. Pilot Procedures
The 510(k) and labeling warning letter pilot does not apply to
the following situations:
1. Advertising and promotion issues;
2. Establishments that manufacture devices as well as other FDA
regulated products;
3. Establishments that manufacture devices that are regulated
by the Center for Biologics Evaluation and Research (CBER);
4. Any inspection that uncovers CGMP, 510(k), or labeling
deficiencies that may cause serious adverse health consequences;\2\
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\2\ ``Serious adverse health consequences'' are to have the same
meaning as ``serious injury,'' which is defined in
Sec. 803.3(aa)(1).
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5. A compliance followup inspection when the previous
inspection resulted in a warning letter or regulatory action for
quality system, 510(k), or labeling violations;
6. Any inspection that discloses other significant device
violations (e.g., medical device reporting or premarket approval) in
addition to quality system, 510(k), or labeling violations which
warrant the issuance of a warning letter or regulatory action;
7. A situation where the firm's management failed to make
promptly available to FDA personnel all requested information and
records required by regulations or laws enforced by FDA;
8. Devices that were never cleared by FDA with a 510(k) and
were not exempted from this requirement (Sec. 807.81(a)(1) or
(a)(2)) (21 CFR 807.81(a)(1) or (a)(2));
9. A major change or modification in the intended use of the
device (Sec. 807.81(a)(3)(ii)); or
10. Electronic products that emit radiation as defined in 21
CFR 1000.3.
Domestic device inspection reports, with endorsements, that
identify possible 510(k) violations of Sec. 807.81(a)(3)(i) (a
change or modification in the device that could significantly affect
the safety or effectiveness of the device) and/or possible labeling
violations should be forwarded to the Office of Compliance (OC),
Center for Devices and Radiological Health (CDRH), HFZ-306. If CDRH
believes that a warning letter situation exits, OC will notify the
establishment via an untitled letter within 30 working days. The
untitled letter will inform the establishment of the need to correct
the violation by submitting either a new 510(k) or an appropriate
labeling change. CDRH will send a copy of this letter to the home
district. If a warning letter or untitled letter is not warranted,
OC will notify the district by memorandum, facsimile, or electronic
mail. The district will inform the establishment, in writing, that
no correction is required.
Firms will have 15 working days from the date of a CDRH
untitled letter to respond. CDRH will have 30 working days to
evaluate the firm's response. An exception to this timeframe may
occur if CDRH has to consult with the district and/or the firm. If
CDRH
[[Page 11023]]
determines that a firm's response is satisfactory, a warning letter
should not be issued. If CDRH is essentially satisfied with the
firm's response but needs further clarification, it may seek
additional information via telephone or untitled correspondence.
If a firm fails to respond to CDRH's untitled letter, a warning
letter should be sent to the establishment by CDRH when the 15
working day timeframe has expired. If CDRH receives a response to
the untitled letter within 15 working days, CDRH has 30 working days
from the receipt date to determine whether the response is
satisfactory. If the written response is determined to be
unsatisfactory, CDRH should send a warning letter to the
establishment.
When no warning letter is issued by CDRH due to a firm's
satisfactory written response, a postinspectional notification
letter should be sent by CDRH to the establishment, with a copy to
the home district, which includes the following language:
``While this inspection found deficiencies concerning [insert
`premarket notification (510(k)),' `labeling,' or both as
appropriate] that would warrant a warning letter if uncorrected,
your written response has satisfied us that you either have taken or
are taking appropriate corrective actions. At this time, FDA does
not intend to take further action based on these inspectional
findings. The agency is relying on your commitment regarding
corrective actions and, should we later observe that these
deficiencies have not been remedied, future regulatory action (e.g.
seizure, injunction and civil penalties) may be taken without
further notice.''
When a CDRH decision is made not to send a warning letter due
to a satisfactory written response from the firm, the district
should classify the inspection as VAI for the labeling or 510(k)
issues.
When no warning letter is issued, as described previously, and
the next inspection of the firm discloses significant 510(k) and/or
labeling deficiencies, then FDA personnel should proceed as if a
warning letter had been issued for the previous inspection and
consider appropriate enforcement action.
C. Administrative
Copies of all warning letters will be forwarded to the Division
of Compliance Management and Operations (DCMO), Office of
Enforcement (OE) (HFC-210). When warning letters are not issued for
510(k) or labeling deficiencies under this pilot, copies of the
postinspectional notification letters issued for inspections that
are initiated between March 29, 1999, and September 8, 2000, should
be sent to Jeffrey B. Governale, Division of Compliance Policy
(DCP)/OE, HFC-230.
CDRH's OC will monitor the warning and postinspectional
notification letters and evaluate the pilot 18 months after it
begins. Any questions about this pilot should be directed to Chester
T. Reynolds, OC/CDRH, HFZ-300.
II. Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments regarding this pilot
program. Two copies of any comment 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.
Comments will be considered in determining whether to revise, revoke,
or adopt this pilot program on a permanent basis. Received comments may
be seen in the office above between 9 a.m. and 4 p.m., Monday through
Friday.
III. Electronic Access
A copy of the pilot may also be downloaded to a personal computer
with access to the World Wide Web (WWW). The Office of Regulatory
Affairs (ORA) and the CDRH home pages include the pilot and may be
accessed at ``http://www.fda.gov/ora'' or ``http://www.fda.gov/cdrh'',
respectively. The pilot will be available on the compliance references
or program areas/compliance information pages for ORA and CDRH,
respectively.
Dated: March 1, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-5523 Filed 3-5-99; 8:45 am]
BILLING CODE 4160-01-F