
[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36543-36544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0469]


Draft Guidance for Industry and Food and Drug Administration 
Staff: Applying Human Factors and Usability Engineering To Optimize 
Medical Device Design; 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availability of the draft guidance document entitled ``Draft Guidance 
for Industry and Food and Drug Administration Staff: Applying Human 
Factors and Usability Engineering to Optimize Medical Device Design.'' 
The recommendations in this guidance are intended to improve the safety 
and effectiveness of devices and reduce use error. This draft guidance 
is not final; nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see Sec.  
10.115(g)(5) (21 CFR 10.115(g)(5))), to ensure that the Agency 
considers your comment on this draft guidance before it begins work on 
the final version of the guidance, submit electronic or written 
comments on the draft guidance by September 19, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and Food and 
Drug Administration Staff: Applying Human Factors and Usability 
Engineering to Optimize Medical Device Design'' to the Division of 
Small Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Molly Story, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 2533, Silver Spring, MD 20993-0002, 301-796-1456, 
e-mail: molly.story@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    To understand use-related hazards, it is necessary to have an 
accurate and complete understanding of how a device will be used. 
Understanding and optimizing how people interact with technology is the 
subject of human factors engineering (HFE) and usability engineering 
(UE). HFE/UE considerations that are important to the development of 
medical devices include three major components of the device-user 
system: (1) Device users, (2) device use environments, and (3) device 
user interfaces.
    For safety-critical technologies such as medical devices, the 
process of eliminating or reducing design-related use problems that 
contribute to or cause unsafe or ineffective medical treatment is part 
of a process for controlling overall risk. For devices where harm could 
result from ``use errors,'' the dynamics of user interaction are 
safety-related and should be components of risk analysis and risk 
management. By incorporating these considerations into the device 
development process, manufacturers can reduce the overall risk level 
posed by their devices, thus decreasing adverse events associated with 
the device, and avoid potential device recalls.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the Agency's current thinking on human 
factors engineering for medical devices. 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 requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability is available for all CDRH 
guidance documents at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Draft Guidance for Industry and Food and Drug Administration Staff: 
Applying Human Factors and Usability Engineering to Optimize Medical 
Device Design.'' you may either send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1757 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of 
information found in FDA regulations. These

[[Page 36544]]

collections of information are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
820 are approved under OMB control number 0910-0073; the collections of 
information in 21 CFR part 812 are approved under OMB control number 
0910-0078; the collections of information in 21 CFR part 807, subpart E 
are approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814, subpart B are approved under OMB 
control number 0910-0231; the collections of information in 21 CFR part 
814, subpart H are approved under OMB control number 0910-0332; and the 
collections of information in 21 CFR part 801 are approved under OMB 
control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 17, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-15570 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P


