[Federal Register Volume 64, Number 150 (Thursday, August 5, 1999)]
[Notices]
[Pages 42700-42701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20089]



[[Page 42700]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2167]


Medical Devices; Draft Guidance on the Likelihood of Facilities 
Inspections When Modifying Devices Subject to Premarket Approval; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Draft Guidance on the 
Likelihood of Facilities Inspections When Modifying Devices Subject to 
Premarket Approval.'' The industry has experienced difficulties in 
planning the implementation of manufacturing and/or other changes 
involving a device with an approved premarket approval application 
(PMA), product development protocol (PDP), or humanitarian device 
exemption (HDE), when an FDA inspection may or may not be necessary. 
This draft guidance will help firms determine whether an FDA inspection 
is needed and more easily manage the timeframes associated with 
implementing changes in manufacturing while maintaining necessary 
safeguards. This guidance is not final nor is it in effect at this 
time.

DATES: Written comments concerning this draft guidance must be 
submitted by November 3, 1999.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5'' diskette of the guidance entitled ``Draft 
Guidance on the Likelihood of Facilities Inspections When Modifying 
Devices Subject to Premarket Approval'' to the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-443-8818.

     Submit written comments on the draft guidance to the Dockets 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

FOR FURTHER INFORMATION CONTACT: Walter W. Morgenstern, Center for 
Devices and Radiological Health (HFZ-305), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4699.

SUPPLEMENTARY INFORMATION:

I. Background

    During recent FDA/medical device industry grassroots forums, 
industry representatives discussed difficulties they have experienced 
in planning for changes related to devices with applications approved 
through the premarket approval (PMA), product development protocol 
(PDP) or humanitarian device exemption (HDE) processes. The industry 
representatives indicated that much of the difficulty was caused by 
uncertainty about FDA policies on what circumstances require submission 
of a PMA supplement, when a PMA inspection may be required, or when 
documenting the change in the firm's files may be adequate.
    FDA, with input from interested parties, developed this draft 
guidance in an effort to help firms manage the timeframes associated 
with implementing changes in manufacturing facilities, manufacturing 
methods or procedures, labeling or performance.
    This draft guidance identifies factors that are involved in 
determining the following: (1) Whether a change in manufacturing 
methods or procedures can be implemented and the device can be 
distributed without prior notice to FDA without any delay except that 
necessary to achieve compliance with the requirements of the Quality 
System/GMP regulation (21 CFR part 820); (2) whether a change in 
manufacturing methods or procedures can be implemented and the device 
can be distributed 30 days after prior written notice has been filed 
with FDA (30-Day Notice) in accordance with section 515(d)(6)(A)(i) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360e(d)(6)(A)(i)) and 21 CFR 814.39, unless FDA notifies the holder of 
the PMA that the notice is inadequate; or (3) whether a change in 
facilities can be accelerated when a firm meets the prerequisite 
conditions for an Express PMA Supplement for Facilities Change.
    The guidance is intended to reduce the regulatory burdens and 
concomitant delays in the implementation of a manufacturing change 
while maintaining necessary safeguards. The factors that an applicant 
and/or FDA should take into consideration when determining the need for 
submission of a supplement and the likelihood of an inspection are 
presented in a model decision procedure.
    This draft guidance represents the agency's current thinking on 
changes to devices with approved PMA's, PDP's or HDE's. 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 requirements of the applicable statute, 
regulation, or both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This document is issued as a Level 1 draft guidance consistent 
with GGP's.

II. Electronic Access

    In order to receive the ``Draft Guidance on the Likelihood of 
Facilities Inspections When Modifying Devices Subject to Premarket 
Approval'' via your fax machine, call the CDRH Facts-On-Demand (FOD) 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At 
the first voice prompt press 1 to access DSMA Facts. At the second 
voice prompt press 2, and then enter the document number (1269) 
followed by the pound sign (#). Then follow the remaining voice prompts 
to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the World Wide Web (WWW). CDRH maintains an entry on the WWW 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the WWW. 
Updated on a regular basis, the CDRH home page includes the draft 
guidance on device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''.

III. Comments

    Interested persons may, on or before November 3, 1999, submit to 
the Dockets Management Branch (address above) written comments 
regarding this draft guidance. 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. A copy of the draft guidance and received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.


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    Dated: July 27, 1999
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-20089 Filed 8-4-99; 8:45 am]
BILLING CODE 4160-01-F