[Federal Register Volume 68, Number 29 (Wednesday, February 12, 2003)]
[Notices]
[Pages 7125-7126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0645]


Medical Device Warning Letter Pilot Termination

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
termination of the Medical Device Warning Letter Pilot (MDWLP). This 
pilot concerns the issuance of warning letters for quality system, 
premarket notification (510(k)), and labeling violations. The intent is 
to inform the

[[Page 7126]]

medical device industry of FDA's decision to discontinue this pilot 
program.

DATES: The effective date for ending the MDWLP is March 14, 2003 for 
inspections or investigations initiated on or after that date.

FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Office of 
Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-0411, FAX 301-827-0482.

SUPPLEMENTARY INFORMATION:

I. Background

    During the FDA and medical device industry grassroots forums, 
several issues were discussed concerning the agency's interaction with 
the device industry. After considering these issues, the agency 
initiated the MDWLP on March 29, 1999. (See the Federal Register of 
March 8, 1999 (64 FR 11018), for a copy of the pilot.) The purpose of 
this pilot was to optimize resource utilization, enhance communication 
between the medical device industry and FDA, and provide firms with 
incentives to promptly correct violations or deficiencies. The MDWLP 
included 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 was restricted to the medical 
device industry and was one of several medical device industry 
initiatives. FDA continued this pilot after the scheduled termination 
date of September 8, 2000, while evaluating its effectiveness.
    After evaluating its effectiveness, FDA has decided to discontinue 
the pilot. The pilot was intended to optimize resource utilization, 
enhance communication between the medical device industry and FDA, and 
provide firms with incentives to promptly correct violations or 
deficiencies. However, FDA has determined that the pilot has not 
provided incentives to promptly correct violations because firms that 
would have received warning letters if not for the pilot, did not have 
measurably better rates of compliance in followup inspections than did 
firms that received warning letters. Also, FDA found that the pilot did 
not optimize resource utilization in that while the quantity of timely 
responses to inspectional observations increased, the quality of those 
responses generally decreased. Thus, FDA determined that the additional 
burdens placed on field staff by the pilot failed to optimize resources 
and reduced overall field inspectional effectiveness.
    Additionally, on November 29, 2001, the Department of Health and 
Human Services directed FDA to submit all warning letters and untitled 
letters to FDA's Office of the Chief Counsel prior to their issuance 
for review of legal sufficiency and consistency with agency policy. 
FDA's new procedures for review of warning and untitled letters address 
some of the concerns that the medical device industry originally 
expressed to FDA during the grassroots meetings. The procedures have 
the added benefit of applicability to all FDA programs. They are 
expected to enhance consistency with agency policy among FDA district 
offices and centers, improve the legal sufficiency and quality of 
enforcement correspondence, and provide for timely feedback to 
regulated entities.
    For all of these reasons, the agency has decided to discontinue the 
MDWLP.

II. Electronic Access

    A copy of the MDWLP may be downloaded to a personal computer with 
access to the Internet at http://www.fda.gov/ohrms/dockets/98fr/030899e.pdf.

    Dated: February 4, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-3436 Filed 2-11-03; 8:45 am]
BILLING CODE 4160-01-S