[Federal Register Volume 64, Number 148 (Tuesday, August 3, 1999)]
[Notices]
[Pages 42138-42139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2152]


Medical Devices; Device Use Safety: Incorporating Human Factors 
in Risk Management; 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availability of the draft guidance entitled ``Draft Guidance on Device 
Use Safety: Incorporating Human Factors in Risk Management.'' This 
draft guidance is neither final nor is it in effect at this time. This 
draft guidance describes how to incorporate human factors techniques 
and theory into risk management during the development of medical 
devices. The draft guidance is intended to assist both reviewers of 
premarket device submissions and manufacturers that develop devices. 
The draft guidance is expected to decrease problems with the use of 
medical devices that impact safety and effectiveness and help ensure 
safer and more effective devices.

DATES: Written comments concerning this draft guidance must be 
submitted by November 1, 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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance entitled 
``Draft Guidance on Device Use Safety: Incorporating Human Factors in 
Risk Management'' 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 two self-
addressed adhesive labels 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    Submit written comments on the draft guidance to the Dockets 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: Ron D. Kaye, Center for Devices and 
Radiological Health (HFZ-230), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3265.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft guidance provides a suggested approach for integrating

[[Page 42139]]

human factors within risk management for medical device design and 
development. It also contains an introduction to both risk management 
and human factors and a discussion of how they are linked. The focus is 
on reducing risks related specifically to the use of medical devices. 
Human factors techniques are discussed in the context of management. 
The draft guidance also suggests how human factors-risk management 
efforts should be documented and included in premarket submissions.
    This draft guidance document represents the agency's current 
thinking on applying human factors to new medical device design and 
development to help ensure that use of a device will be safe and 
effective. 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 applicable statute, 
regulations, 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 draft guidance document is issued as a Level 1 guidance 
consistent with GGP's.

II. Electronic Access

    In order to receive ``Draft Guidance on Device Use Safety: 
Incorporating Human Factors in Risk Management'' 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 second voice prompt press 2, and then enter the 
document number (1497) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft 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 Use Safety: Incorporating Human Factors in 
Risk Management,'' 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''. The ``Draft Guidance on Device Use Safety: 
Incorporating Human Factors in Risk Management'' will be available at 
``http://www.fda.gov/cdrh/HumanFactors.html''.

III. Comments

    Interested persons may submit written comments regarding this draft 
guidance. Two copies of any comments are to be submitted to Dockets 
Management Branch (address above), except that individuals may submit 
one copy. Comments should be identified with the docket number found in 
brackets in the heading of this document. A copy of the draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: July 20, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-19870 Filed 8-2-99; 8:45 am]
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