[Federal Register Volume 61, Number 58 (Monday, March 25, 1996)]
[Notices]
[Pages 12075-12076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7047]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0065]
``Medical Device Design Control Guidance'' and ``Do It By
Design;'' Draft Guidance; Availability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availability of two draft guidance documents entitled, ``Medical Device
Design Control Guidance'' and ``Do It By Design.'' The ``Medical Device
Design Control Guidance'' draft document is intended to provide a
general understanding of design control theory, principles, and
methods, and to update a previous guidance document on the subject of
preproduction quality assurance. The ``Do It By Design'' draft guidance
document is intended to provide a general understanding of the human
factors theory as it relates to designing a medical device. Both draft
guidance documents, once finalized, are intended to be basic
educational tools for industry and FDA field investigators, and they
will be used to aid implementation of the new ``quality system
regulation,'' now in the final stages of development.
DATES: Written comments by April 30, 1996.
ADDRESSES: Submit written requests for single copies of the draft
guidances to the Division of Small Manufacturers Assistance (DSMA),
Center for Devices and Radiological Health (HFZ-220), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist the office in processing your
request. Copies of a facsimile of the draft guidances are available
from CDRH Facts on Demand (1-800-899-0381). Copies of the draft
guidances may also be obtained from the Electronic Docket administered
by DSMA and are available to anyone with a video terminal or personal
computer (1-800-252-1366).
Submit written comments to the Dockets Management Branch (HFA-
[[Page 12076]]
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. Comments for the two draft guidance documents
should be kept separate and identified by their respective titles.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. A copy of the draft
guidances and received comments are available for public examination in
the Dockets Management Branch (address above) between 9 a.m. and 4
p.m., Monday through Friday.
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
The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629),
enacted on November 28, 1990, amended section 520(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j (f)), providing FDA with
the authority to add preproduction design controls to the current good
manufacturing practice (CGMP) regulation part 820 (21 CFR part 820).
This change in law was based on findings that a significant proportion
of device recalls were attributed to faulty product design. FDA found
that approximately 44 percent of the quality problems that led to
voluntary recall actions during a 6-year period were attributed to
errors or deficiencies that had been designed into particular devices
and that may have been prevented by adequate design controls. These
design-related defects involved both noncritical devices (e.g., patient
chair lifts, in vitro diagnostics, and administration sets) and
critical devices (e.g., pacemakers and ventilators). Also in 1990, the
Department of Health and Human Services' Inspector General conducted a
study which reached similar conclusions.
FDA undertook the revision of the CGMP regulation to add the design
controls authorized by the SMDA to the CGMP regulation and because the
agency believed that it would be beneficial to the public and the
medical device industry for the CGMP regulation to be consistent, to
the extent possible, with the requirements for quality systems
contained in international standards. The agency's extensive efforts to
revise the CGMP regulation included making publicly available a working
draft of a final rule in July 1995, followed by a public workshop on
August 23, 1995 (see 60 FR 37856, July 24, 1995), and an open public
GMP Advisory Committee meeting on September 13 and 14, 1995 (see 60 FR
44037, August 24, 1995). The final regulation, generally referred to as
the quality system regulation, is now in the final stages of
development.
The ``Medical Device Design Control Guidance'' and ``Do It By
Design'' draft guidance documents are intended to provide assistance in
understanding what design controls are and provide recommendations on
how to establish design controls, which would be consistent with the
new design control requirements. The draft guidance ``Medical Device
Design Control Guidance'' updates the Center for Devices and
Radiological Health's ``Preproduction Quality Assurance Planning:
Recommendations for Medical Device Manufacturers,'' announced as a
final document in the Federal Register of October 5, 1989 (54 FR
41165). The draft guidance documents are projected to be finalized
later this year, soon after the new quality system regulation is
published.
II. Significance of a Guidance
A guidance document does not bind FDA or the public, and does not
create or confer any rights, privileges, or benefits for or on any
person; however, it does represent the agency's current thinking on the
subjects discussed therein. The draft guidance documents announced in
this notice represent the agency's tentative thinking on design
controls and the relationship of human factors with design controls.
III. Request for Comments
Interested persons may, on or before April 30, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
the draft guidances. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified by the title of the respective draft guidance and with the
docket number found in brackets in the heading of this document. The
two draft guidance documents and received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday.
Received comments will be considered in revising the draft guidance
documents.
Dated: March 15, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-7047 Filed 3-22-96; 8:45 am]
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