[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