[Federal Register Volume 65, Number 138 (Tuesday, July 18, 2000)]
[Notices]
[Pages 44539-44540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2152]


Guidance for Industry and FDA Reviewers on Medical Device Use--
Safety: Incorporating Human Factors Engineering into 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 guidance document entitled ``Medical Device Use--
Safety: Incorporating Human Factors Engineering into Risk Management.'' 
This guidance describes how to incorporate human factors techniques and 
theory into risk management during medical device design and 
development. The guidance is intended to assist reviewers of premarket 
device submissions, design control documentation, and manufacturers 
that develop devices. The guidance is necessary to decrease problems 
with the use of medical devices that impact safety and effectiveness, 
and help ensure safer and more effective devices.

DATES:  Submit written comments on agency guidances at any time.

ADDRESSES:  Submit written requests for single copies on a 3.5" 
diskette of the guidance document entitled ``Medical Device Use--
Safety: Incorporating Human Factors Engineering into 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 ``Medical Device 
Use--Safety: Incorporating Human Factors Engineering into Risk 
Management'' to the contact person listed below. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.

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, 301-443-2436.

SUPPLEMENTARY INFORMATION:

I. Background

    The guidance is intended to provide a suggested approach for 
integrating 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 hazards related specifically to the use of 
medical devices. Human factors techniques are discussed within the 
context of applying risk management. The guidance also suggests how 
human factors-risk management efforts should be documented and included 
in premarket submissions. This guidance document was published for 
public comment on August 3, 1999, as a draft guidance entitled ``Device 
Use Safety: Incorporating Human Factors in Risk Management.'' The 
document has been modified from the original draft version to address 
public comments. There were changes made in the document for the 
purposes of clarity, but there were no major substantive changes.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the application of human factors to new medical device design and 
development to help ensure that intended users can use a device safely 
and effectively. 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 guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive ``Medical Device Use--Safety: Incorporating 
Human Factors Engineering into Risk Management'' via your fax machine, 
call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-
0111 from a touchtone 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 guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes ``Medical Device Use--
Safety: Incorporating Human Factors Engineering into 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. ``Medical Device Use--Safety: 
Incorporating Human Factors Engineering into Risk Management'' is also 
available at http://www.fda.gov/cdrh/HumanFactors.html.

IV. Comments

    Interested persons may, at any time, submit written comments on the 
guidance to the contact person (address above). Such comments will be 
considered when determining whether to amend the current guidance. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be

[[Page 44540]]

identified with the docket number found in brackets in the heading of 
this document. The 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 5, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-18061 Filed 7-17-00; 8:45 am]
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