[Federal Register Volume 60, Number 141 (Monday, July 24, 1995)]
[Proposed Rules]
[Pages 37856-37858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18080]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

[Docket No. 90N-0172]
RIN No. 0905-AD59


Medical Devices; Working Draft of the Current Good Manufacturing 
Practice (CGMP) Final Rule; Notice of Availability; Request for 
Comments; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability and announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a working draft of a final rule on the revision of the 
current good manufacturing practice (CGMP) regulation for devices 
(quality system regulation). The quality system regulation includes 
requirements related to the methods used in and the facilities and 
controls used for: Designing, purchasing, manufacturing, packaging, 
labeling, storing, installing, and servicing of medical devices 
intended for human use. The working draft contains a number of changes 
made in response to the many comments received on the proposal to amend 
the CGMP regulation, and it represents the agency's view of the 
necessary elements of a CGMP regulation. In this document, FDA is also 
announcing a public meeting to be held on the working draft. At a later 
time, FDA will announce a meeting of the Device Good Manufacturing 
Practice Advisory Committee. The publication of this document is 
intended to make the working draft of the quality system regulation 
available to the public in order to give those who will attend the 
public meetings the opportunity to be informed of the agency's current 
thinking on the final rule and to allow interested parties an 
additional opportunity to comment before a final regulation is issued.

DATES: The public meeting will be held on Wednesday, August 23, 1995, 
from 9 a.m. to 4:30 p.m. Should more time be needed, Thursday, August 
24, 1995, has been set aside for this purpose. Interested persons, 
whether or not they are able to attend, may submit written comments on 
the issues described in this notice by October 23, 1995. Submit written 
notices of participation on or before August 8, 1995. Any final 
regulation that may issue, after a thorough review of the comments 
received on this working draft, will become effective 180 days 
following its publication in the Federal Register. A transcript of the 
meeting will be available from the Dockets Management Branch (address 
below).
ADDRESSES: The meeting will be held at the Parklawn Bldg, conference 
room D, 5600 Fishers Lane, Rockville, MD. There is no registration fee 
for this meeting. Submit written requests to make a presentation at the 
meeting to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 
Submit written requests for single copies of the working draft of the 
quality system regulation to the Division of Small Manufacturers 
Assistance (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed adhesive labels to assist 
that office in processing your request. Submit written comments on the 
working draft to the Dockets Management Branch (HFA-305) (address 
above). Requests and comments should be identified with the docket 
number found in brackets in the heading of this document. A copy of the 
working draft and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday. Copies of a facsimile of the working draft, 
totaling approximately 230 pages (approximately 190 pages of draft 
preamble and 40 pages of draft regulation), are available from CDRH 

[[Page 37857]]
Facts on Demand (1-800-899-0381). Copies of the revision may also be 
obtained from the electronic docket administered by the Division of 
Small Manufacturers Assistance and are available to anyone with a video 
terminal or personal computer (1-800-252-1366).

FOR FURTHER INFORMATION CONTACT: Kimberly A. Trautman, Office of 
Compliance, Center for Devices and Radiological Health (HFZ-341), Food 
and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-
594-4648.

SUPPLEMENTARY INFORMATION:

I. Background

    Manufacturers establish and follow quality systems to help ensure 
that their products consistently meet applicable requirements and 
specifications. The quality systems for FDA regulated products (food, 
drugs, biologics, and devices) are known as CGMP's. CGMP requirements 
for devices (part 820 (21 CFR part 820)) were first authorized by 
section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360j(f)), which was among the authorities added to the act 
by the Medical Device Amendments of 1976 (Pub. L. 94-295). The Safe 
Medical Devices Act (the SMDA) of 1990 (Pub. L. 101-629), enacted on 
November 28, 1990, amended section 520(f) of the act, providing FDA 
with the explicit authority to add preproduction design validation 
controls to the CGMP regulation. The SMDA also added a new section 803 
to the act (21 U.S.C. 383) which, among other things, encourages FDA to 
work with foreign countries toward mutual recognition of CGMP 
requirements. -
    FDA undertook the revision of the CGMP regulation in part to add 
the design controls authorized by the SMDA to the CGMP regulation, and 
in part because the agency believes that it would be beneficial to the 
public, as well as the medical device industry, for the CGMP regulation 
to be consistent, to the extent possible, with the requirements for 
quality systems contained in applicable international standards, 
namely, the International Organization for Standards (ISO) 9001:1994 
``Quality Systems--Model for Quality Assurance in Design, Development, 
Production, Installation, and Servicing'' (Ref. 1), and the ISO working 
draft revision of ISO/DIS 13485 ``Quality Systems--Medical Devices--
Supplementary Requirements to ISO 9001'' (Ref. 2), among others. The 
preamble to the November 23, 1993, proposal contained a detailed 
discussion of the history of the device CGMP regulation, from the 
agency's initial issuance of the regulation through FDA's decision to 
propose revising the regulation.-
    The agency's working draft embraces the same ``umbrella'' approach 
to CGMP regulation that is the underpinning of the existing CGMP 
regulation. Thus, because this regulation must apply to so many 
different types of devices, the regulation does not prescribe in detail 
how a manufacturer must produce a specific device. Rather, the 
regulation lays the framework that all manufacturers must follow, 
requiring that the manufacturer develop and follow procedures, and fill 
in the details, that are appropriate to a given device according to the 
current state-of-the-art manufacturing for that specific device. FDA 
has made further changes to the proposed regulation, as the working 
draft evidences, to provide manufacturers with even greater flexibility 
in achieving the quality requirements.

II. Decision to Make a Working Draft Available for Comment

    On November 23, 1993 (58 FR 61952), the agency issued the proposed 
revisions to the CGMP regulation, entitled ``Medical Devices; Current 
Good Manufacturing Practice (CGMP) Regulations; Proposed Revisions; 
Request for Comments,'' and public comment was solicited. After the 
proposal issued, FDA met with the Global Harmonization Task Force 
(GHTF) Study Group in early March 1994, in Brussels, to compare the 
provisions of the proposal with the provisions of ISO 9001:1994 and 
European National (EN) standard EN 46001 ``Quality Systems--Medical 
Devices--Particular Requirements for the Application of EN 29001.'' The 
GHTF includes: Representatives of the Canadian Ministry of Health and 
Welfare; the Japanese Ministry of Health and Welfare; FDA; and industry 
members from the European Union, Australia, Canada, Japan, and the 
United States. The participants at the GHTF meeting favorably regarded 
FDA's effort toward harmonization with international standards. The 
GHTF submitted comments, however, noting where FDA could more closely 
harmonize to achieve consistency with quality system requirements 
worldwide. Since the proposal published, FDA has also attended numerous 
industry and professional association seminars and workshops, including 
ISO Technical Committee 210 ``Quality Management and Corresponding 
General Aspects for Medical Devices'' meetings, where the proposed 
revisions were discussed.
    The original period for comment on the proposal closed on February 
22, 1994, and was extended until April 4, 1994. Because of the heavy 
volume of comments and the desire to increase public participation in 
the development of the quality system regulation, FDA decided to 
publish this notice of availability in the Federal Register to allow 
comment on the working draft, to be followed by two public meetings, as 
described below, before issuing a final regulation.
    This working draft represents the agency's current views on how it 
would respond to the many comments received, and on how the agency 
believes a final rule should be framed. FDA solicits public comment on 
this working draft to determine if the agency has adequately addressed 
the many comments received and whether the agency has framed a final 
rule that achieves the public health goals to be gained from 
implementation of quality systems in the most efficient manner.

III. Opportunity for Public Meeting

     FDA intends to hold two public meetings on the revision of the 
quality system regulation. One meeting, which will be held pursuant to 
21 CFR part 10.65(b), is scheduled for August 23, 1995. Interested 
persons who wish to participate in the public meeting may, on or before 
August 8, 1995 submit a written notice of participation to the Dockets 
Management Branch (address above). All notices submitted should be 
identified with the docket number found in brackets in the heading of 
this document and should be clearly marked ``Notice of Participation.'' 
The notice should also contain the name, address, telephone number, 
business affiliation of the person requesting to make a presentation, a 
brief summary of the presentation, and the approximate time requested 
for the presentation.
     Individuals or groups having similar interests are requested to 
consolidate their comments and present them through a single 
representative. FDA may require joint presentations by persons with 
common interests. FDA will allocate the time available for the meeting 
among the persons who properly submit a written notice of 
participation. The meeting is informal, and the rules of evidence do 
not apply.
     Because of the complexity of the issues to be discussed at the 
public meeting, FDA has concluded that it would not be beneficial to 
the meeting participants or the agency to devote the entire meeting to 
public presentations. Therefore, after reviewing the notices of 

[[Page 37858]]
participation and accompanying information, FDA will schedule each 
appearance and notify each participant by mail or telephone of the time 
allotted to the person and the approximate time the person's 
presentation is scheduled to begin. Each presentation will be limited 
in time in order to provide sufficient time for prepared presentations 
by the agency followed by a discussion period. The schedule of the 
public meeting will be available at the meeting, and later it will be 
placed on file in the Dockets Management Branch (address above).
     Individuals and organizations that do not submit a notice of 
participation but would like to testify will have the opportunity, if 
time permits. A transcript of the proceedings of the public meeting, as 
well as all data and information submitted voluntarily to FDA during 
the public meeting to discuss the working draft, will become part of 
the administrative record and will be available to the public under 21 
CFR 20.111 from the Dockets Management Branch (address above).
     While oral presentations from specific individuals and 
organizations will be limited during the public meeting, the written 
comments submitted as part of the administrative record may contain a 
discussion of any issues of concern. All relevant data and 
documentation should be submitted with the written comments.
     There will also be a public meeting with the Device GMP Advisory 
Committee, established under section 520(f)(1)(B) of the act, on the 
working draft. That meeting will be governed by part 14 (21 CFR part 
14) of FDA's administrative practices and procedures regulations, which 
specifies the requirements for filing notices of appearance. The 
tentative dates for the meeting are September 13 and 14, 1995. A notice 
of the exact dates, time, and place for the meeting will appear in a 
future issue of the Federal Register. After considering the written 
comments and the views expressed at the public meeting and at the 
September advisory committee meeting, FDA will publish a final rule in 
the Federal Register.

IV. References

    The following information has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday:
    (1) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design, Development, Production, Installation, and Servicing.''
    (2) ISO working draft revision of ISO/DIS 13485 ``Quality 
Systems--Medical Devices--Supplementary Requirements to ISO 9001.''

V. Comments

    Interested persons may, on or before October 23, 1995, submit to 
the Dockets Management Branch (address above), written comments 
regarding this working draft. 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 working draft and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-18080 Filed 7-19-95; 1:36 pm]
BILLING CODE 4160-01-F