Notice2023-19404
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff; Availability
Primary source
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Published
September 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled "Application of Human Factors Engineering Principles for Combination Products: Questions and Answers." This document provides questions and answers for industry and FDA staff on the application of human factors engineering (HFE) principles to the development of combination products as defined under the regulations. The guidance clarifies how the unique aspects of a combination product influence the considerations within the HFE process. This guidance is intended to facilitate the development of combination products. This guidance finalizes the draft guidance entitled "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" issued on February 3, 2016.
Full Text
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<title>Federal Register, Volume 88 Issue 173 (Friday, September 8, 2023)</title>
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[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62093-62094]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19404]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-4848]
Application of Human Factors Engineering Principles for
Combination Products: Questions and Answers; Guidance for Industry and
FDA Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry and FDA staff
entitled ``Application of Human Factors Engineering Principles for
Combination Products: Questions and Answers.'' This document provides
questions and answers for industry and FDA staff on the application of
human factors engineering (HFE) principles to the development of
combination products as defined under the regulations. The guidance
clarifies how the unique aspects of a combination product influence the
considerations within the HFE process. This guidance is intended to
facilitate the development of combination products. This guidance
finalizes the draft guidance entitled ``Human Factors Studies and
Related Clinical Study Considerations in Combination Product Design and
Development'' issued on February 3, 2016.
DATES: The announcement of the guidance is published in the Federal
Register on September 8, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, 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-4848 for ``Application of Human Factors Engineering
Principles for Combination Products: Questions and Answers.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Office of
[[Page 62094]]
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Patricia Love, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Avenue,
Bldg. 32, Rm. 5129, Silver Spring, MD 20993, 301-796-8930,
<a href="/cdn-cgi/l/email-protection#13437267617a707a723d5f7c6576537577723d7b7b603d747c65"><span class="__cf_email__" data-cfemail="b2e2d3c6c0dbd1dbd39cfeddc4d7f2d4d6d39cdadac19cd5ddc4">[email protected]</span></a> or <a href="/cdn-cgi/l/email-protection#50333f3d32393e3124393f3e103634317e373f26"><span class="__cf_email__" data-cfemail="a0c3cfcdc2c9cec1d4c9cfcee0c6c4c18ec7cfd6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Application of Human Factors Engineering
Principles for Combination Products: Questions and Answers.'' This
guidance provides questions and answers for industry and FDA staff on
the application of HFE principles to the development of combination
products as defined under 21 CFR part 3. This guidance should be used
in conjunction with the guidance for industry and FDA staff ``Applying
Human Factors and Usability Engineering to Medical Devices'' (available
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices</a>) and with the guidance for industry ``Safety Considerations for
Product Design to Minimize Medication Errors'' (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-product-design-minimize-medication-errors-guidance-industry">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-product-design-minimize-medication-errors-guidance-industry</a>).
This guidance focuses on considerations for the application of HFE
principles to combination products comprised of a medical device
combined with a drug or a biological product submitted for review in
the Center for Biologics Evaluation and Research, the Center for
Devices and Radiological Health, or the Center for Drug Evaluation and
Research. This guidance discusses, among other things, the definition
of a combination product critical task, considerations for combination
products due to the use of a drug or biological product constituent
part together with a device constituent part, training as part of the
user interface, and human factors (HF) validation data to support the
combination product user interface that may be included in a premarket
submission.
This guidance finalizes the draft guidance entitled ``Human Factors
Studies and Related Clinical Study Considerations in Combination
Product Design and Development'' issued on February 3, 2016 (81 FR
5764). FDA considered comments received on the draft guidance as the
guidance was finalized. Changes from the draft to the final guidance
include: change in format to a questions and answers format, deletion
of HF information that is redundant with other FDA guidance documents
and focusing the guidance on combination product specific issues,
providing additional information in response to comments, clarification
of the combination product critical task definition, further
explanation of considerations to help identify combination product
critical tasks, and replacement of an appendix of examples of user task
failures with examples that provide a contextual discussion of
combination product critical task considerations. In addition,
editorial changes were made to improve clarity.
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 ``Application of Human Factors Engineering
Principles for Combination Products: Questions and Answers.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for 21 CFR part 312 for investigational new drug
applications have been approved under OMB control number 0910-0014 and
the collections of information for 21 CFR part 812 for investigational
device exemptions have been approved under OMB control number 0910-
0078. The collections of information in 21 CFR part 314 for new drug
applications have been approved under OMB control number 0910-0001 and
the collections of information in 21 CFR part 601 for biologics license
applications have been approved under OMB control number 0910-0338. The
collections of information in 21 CFR part 814, subparts A through E for
premarket approval applications have been approved under OMB control
number 0910-0231. The collections of information in 21 CFR part 807,
subpart E for premarket notifications have been approved under OMB
control number 0910-0120 and the collections of information in 21 CFR
860, subpart D for De Novo classifications have been approved under OMB
control number 0910-0844.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents">https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19404 Filed 9-7-23; 8:45 am]
BILLING CODE 4164-01-P
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