[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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availability of the draft guidance entitled ``Draft Guidance on Device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draft guidance is neither final nor is it in effect at this time.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draft guidance describes how to incorporate human factors techniques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 The draft guidance is intended to assist both reviewers of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The draft guidance is expected to decrease problems with the use of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DATES: Written comments concerning this draft guidance must be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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance entitled
``Draft Guidance on Device Use Safety: Incorporating Human Factors in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Submit written comments on the draft guidance to the Dockets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The draft guidance provides a suggested approach for integrating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]
BILLING CODE 4160-01-F
