[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Notices]
[Pages 45821-45825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0645]


Medical Device Warning Letter Draft Pilot; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is planning to initiate 
a pilot program involving the medical device industry that is a 
continuation of the ``medical device industry initiatives.'' This draft 
pilot concerns the issuance of warning letters for quality system, 
premarket notification submission (510(k)), and labeling violations. 
This draft 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 draft 
pilot includes eligibility criteria and procedures for the issuance of 
warning letters and will not be implemented until after the public 
comment period has expired.

DATES: Written comments on the draft pilot may be submitted by October 
13, 1998.

ADDRESSES: Submit written comments on the draft 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 
draft pilot.

FOR FURTHER INFORMATION CONTACT: 
    Device quality system warning letter draft 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 draft 
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 recent 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 
plans to initiate a pilot program that will last for 18 months, and 
then be formally evaluated. The draft pilot includes procedures for the 
issuance of warning letters for quality system (21 CFR part 820), 
510(k) (part 807, subpart E) (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 draft pilot is currently restricted to the 
medical device industry and is a continuation of the medical device 
industry initiatives.
    FDA currently maintains contracts with the States of California, 
Colorado, and Texas that will expire on September 30, 1998, to conduct 
medical device inspections on behalf of FDA. This draft pilot does not 
include those inspections done under State contract for FDA. However, 
noncontract medical device inspections done by FDA personnel in these 
States will be eligible for this draft pilot.
    The purpose of this draft 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 draft pilot will not 
impact on violative situations where enforcement action is necessary to 
protect the public health.
    The medical device warning letter draft 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 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). This pilot is being issued as a draft level 1 guidance 
consistent with GGP's.
    The draft pilot consists of two parts that are described as 
follows:

I. Device Quality System Warning Letter Draft Pilot

     Dates: (insert initiation and ending dates 18 months apart)
    This draft 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.
    This draft 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. An inspection that uncovered CGMP, premarket notification 
submission (510(k)), or labeling deficiencies that may cause serious 
adverse health consequences;
    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. An inspection that 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; or
    8. A situation where the firm's management failed to make 
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 to respond to the 
establishment. 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

[[Page 45822]]

document) should be sent to the establishment.
    When a decision is made not to send a warning letter due to a 
satisfactory written response from the firm, the inspection should 
be classified as voluntary action indicated (VAI) and the profile 
should be designated as acceptable.
    When no warning letter is issued, as described previously, 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 draft pilot as attachment 2 and table 1 for attachment 3.)
    This draft 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 (insert initiation date) and (insert date 18 
months after start date) should be forwarded 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 draft 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).
    Any questions concerning this draft 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 Draft 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 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)

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[[Page 45823]]

[GRAPHIC] [TIFF OMITTED] TN27AU98.000


BILLING CODE 4160-01-C

[[Page 45824]]

Attachment 3--Device Quality System Warning Letter Draft Pilot

    Important
    If one or more of your answers to any of the questions are 
different than those found in the answer column of this Table, 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         
----------------------------------------------------------------------------------------------------------------
 1............  In addition to devices, does the establishment manufacture other FDA   No                       
                 regulated products?                                                                            
2.............  Does the establishment manufacture devices that are regulated by       No                       
                 CBER?                                                                                          
3.............  Is the establishment a recidivous firm per CP 7382.830?                No                       
4.............  Did the inspection uncover CGMP, 510(k), or labeling deficiencies      No                       
                 that may cause serious adverse health consequences?                                            
5.............  Was this a compliance followup inspection to a warning letter or       No                       
                 regulatory action for quality system, 510(k), or labeling                                      
                 violations?                                                                                    
6.............  Did the inspection disclose other significant device violations in     No                       
                 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 available to FDA all required           Yes                      
                 information that was requested?                                                                
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Attachment 4--Cover Page for the Device Quality System Warning Letter 
Draft 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 for one or more of the following reasons. Please check 
the appropriate reason(s):
    ______  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 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 Draft 
Pilot

     Dates: (insert initiation and ending dates 18 months apart)

A. Background

    The impetus for this draft 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 draft pilot has been developed in response to 
the device industry's concerns. The purpose of this draft pilot is 
to determine if notifying firms about 510(k) and labeling issues, in 
lieu of a warning letter, will result in the efficient resolution of 
the issues.

B. Draft Pilot Procedures

    The 510(k) and labeling warning letter draft 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. An inspection that uncovered CGMP, 510(k), or labeling 
deficiencies that may cause serious adverse health consequences;
    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. An inspection that 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;
    7. A situation where the firm's management failed to make 
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 via a 510(k) and were 
not exempted from this requirement (Sec. 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 situation/correction 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 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

[[Page 45825]]

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 and the profile as acceptable 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 (insert initiation date) and (insert date that 
is 18 months after the initiation date) 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 1 year after it begins. 
Any questions about this pilot should be directed to Chester T. 
Reynolds, OC/CDRH, HFZ-300.

II. Request for Comments

    Interested persons may, on or before October 13, 1998, submit to 
the Dockets Management Branch (address above) written comments on the 
draft pilot. Two copies of any comments 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. The agency will review all comments, but in issuing a final 
pilot program need not specifically address every comment. The agency 
will make changes to the draft pilot in response to comments, as 
appropriate. Copies of the draft pilot and received comments may be 
seen in the Dockets Management Branch (address above) between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    A copy of the draft 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 draft 
pilot and may be accessed at ``http://www.fda.gov/ora'' or ``http://
www.fda.gov/cdrh'', respectively. The draft pilot will be available on 
the compliance references or compliance information pages for ORA and 
CDRH, respectively.

    Dated: August 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23027 Filed 8-26-98; 8:45 am]
BILLING CODE 4160-01-F