[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62093-62094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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finalizes the draft guidance entitled ``Human Factors Studies and 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 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, 
[email protected] or [email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices) and with the guidance for industry ``Safety Considerations for 
Product Design to Minimize Medication Errors'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-product-design-minimize-medication-errors-guidance-industry).
    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 
https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    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