
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5762-5763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Applying Human Factors and Usability Engineering to Medical 
Devices; Guidance for Industry and Food and Drug Administration Staff; 
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 entitled ``Applying Human Factors and 
Usability Engineering to Medical Devices.'' FDA has developed this 
guidance document to assist industry in following appropriate human 
factors and usability engineering processes to maximize the likelihood 
that new medical devices will be safe and effective for the intended 
users, uses, and use environments. The recommendations in this guidance 
document are intended to support manufacturers in improving the design 
of medical devices to minimize potential use errors and resulting harm. 
FDA believes that these recommendations will enable manufacturers to 
assess and reduce risks associated with medical device use.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-D-0469 for ``Applying Human Factors and Usability Engineering 
to Medical Devices.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Applying Human Factors and Usability Engineering to Medical Devices'' 
to the Office of the Center Director, Guidance and Policy

[[Page 5763]]

Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Shannon Hoste, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2531, Silver Spring, MD 20993-0002, 240-402-3747 or 
Shannon.hoste@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 in the development of medical devices 
include the 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 should be 
included in 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 avoiding potential device 
recalls.
    In the Federal Register of June 22, 2011 (76 FR 36543), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by September 19, 2011. FDA received 
over 600 comments, which were generally supportive of the draft 
guidance document, but requested clarification in a number of areas. 
The most frequent types of comments requested revisions to the language 
or structure of the document, or clarification on risk mitigation and 
human factors testing methods, user populations for testing, training 
of test participants, determining the appropriate sample size in human 
factors testing, reporting of testing results in premarket submissions, 
and collecting human factors data as part of a clinical study. In 
response to these comments, FDA revised the guidance document to 
clarify the points identified and restructured the information for 
better readability and comprehension. This guidance supersedes the 
guidance entitled ``Medical Device Use-Safety: Incorporating Human 
Factors Engineering into Risk Management'' dated July 18, 2000, which 
will be withdrawn.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Applying Human Factors and Usability 
Engineering to Medical Devices.'' It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Applying Human Factors and 
Usability Engineering to Medical Devices'' may send an email request to 
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the 
document. Please use the document number 1747 to identify the guidance 
you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations and guidance. These 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, subparts A through E 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; the 
collections of information in 21 CFR parts 801 and 809 are approved 
under OMB control number 0910-0485; and the collections of information 
in the guidance document entitled ``Requests for Feedback on Medical 
Device Submissions: The Pre-Submission Program and Meetings with Food 
and Drug Administration Staff'' are approved under OMB control number 
0910-0756.

    Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01887 Filed 2-2-16; 8:45 am]
 BILLING CODE 4164-01-P


