[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Design;'' Draft Guidance; Availability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availability of two draft guidance documents entitled, ``Medical Device 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 The ``Do It By Design'' draft guidance 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 Both draft 
guidance documents, once finalized, are intended to be basic 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 Comments for the two draft guidance documents 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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