[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5756-5758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-4599]
List of Highest Priority Devices for Human Factors Review; Draft
Guidance for Industry and Food and Drug Administration Staff;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 or Agency) is announcing
the availability of the draft guidance entitled ``List of Highest
Priority Devices for Human Factors Review.'' FDA is issuing this draft
guidance document in order to inform medical device manufacturers which
device types should have human factors data included in premarket
submissions. FDA believes these device types have clear potential for
serious harm resulting from use error and that review of human factors
data in premarket submissions will help FDA evaluate the safety and
effectiveness and substantial equivalence of these devices. This draft
guidance is not final nor is it in effect at this time.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 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 3, 2016.
ADDRESSES: You may submit comments as follows:
[[Page 5757]]
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-2015-D-4599 for ``List of Highest Priority Devices for Human
Factors Review.'' 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 draft guidance document entitled
``List of Highest Priority Devices for Human Factors Review'' to the
Office of the Center Director, Guidance and Policy 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 [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Human factors testing is a valuable component of product
development for medical devices. FDA recommends that manufacturers
consider human factors testing for medical devices as a part of a
robust design control subsystem. This draft guidance, if finalized,
will inform medical device manufacturers which device types should have
human factors data included in premarket submissions (i.e., for
premarket approval 510(k)). FDA believes these device types have clear
potential for serious harm resulting from use error and that review of
human factors data in premarket submissions will help FDA evaluate the
safety and effectiveness and substantial equivalence of these devices.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the guidance document, ``Applying Human Factors and
Usability Engineering to Medical Devices,'' 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. Devices
that should include human factors data in premarket submissions are
listed in this draft guidance. When and if this draft guidance is
finalized, FDA recommends that for devices identified in the draft
guidance, manufacturers should provide FDA with a report that
summarizes the human factors or usability engineering processes they
have followed, including any preliminary analyses and evaluations and
human factors validation testing, results, and conclusions.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the list of
highest priority devices for human factors review. 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 draft 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.
[[Page 5758]]
Guidance documents are also available at http://www.regulations.gov.
Persons unable to download an electronic copy of ``List of Highest
Priority Devices for Human Factors Review'' may send an email request
to [email protected] to receive an electronic copy of the
document. Please use the document number 1500052 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. 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. 2016-01889 Filed 2-2-16; 8:45 am]
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