Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center. This guidance finalizes the draft guidance of the same title issued on September 19, 2023.

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<title>Federal Register, Volume 91 Issue 202 (Wednesday, October 21, 2026)</title>
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[Federal Register Volume 91, Number 202 (Wednesday, October 21, 2026)]
[Notices]
[Pages 66561-66563]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2482]


Regulatory Considerations for Prescription Drug Use-Related 
Software; Guidance for Industry; 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 titled ``Regulatory 
Considerations for Prescription Drug Use-Related Software.'' This final 
guidance describes FDA's application of its drug labeling authorities 
to certain software outputs that are disseminated by or on behalf of a 
drug sponsor for use with a prescription drug product or a prescription 
drug-led, drug-device combination product that is assigned to the 
Center for Drug Evaluation and Research or the Center for Biologics 
Evaluation and Research as the lead center. This guidance finalizes the 
draft guidance of the same title issued on September 19, 2023.

DATES: The announcement of the guidance is published in the Federal 
Register on October 21, 2026.

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

[[Page 66562]]

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-2023-D-2482 for ``Regulatory Considerations for Prescription Drug 
Use-Related Software.'' 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 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, 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: Chris Wheeler, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3314, Silver Spring, MD 20993-0002, 301-
796-2500, <a href="/cdn-cgi/l/email-protection#8dcec9c8dfc2c0ddcdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="9bd8dfdec9d4d6cbdbfdfffab5f3f3e8b5fcf4ed">[email&#160;protected]</span></a>; Aneesh Deoras, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5540, Silver Spring, MD 20993-0002, 240-402-4363, 
<a href="/cdn-cgi/l/email-protection#c2a6aba5abb6a3aeaaa7a3aeb6aa82a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="690d000e001d0805010c08051d01290f0d084701011a470e061f">[email&#160;protected]</span></a>; or Phillip Kurs, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 240-402-7911, 
<a href="/cdn-cgi/l/email-protection#2d444349585e595f54034f444241424a444e5e6d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="264f4842535552545f08444f494a49414f455566404247084e4e5508414950">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
titled ``Regulatory Considerations for Prescription Drug Use-Related 
Software.'' This guidance describes how FDA intends to apply its drug 
labeling authorities to certain software outputs that are disseminated 
by or on behalf of a drug sponsor for use with a prescription drug 
product or a prescription drug-led, drug-device combination product. As 
explained in this final guidance, prescription drug use-related 
software generally includes software that (1) is disseminated by or on 
behalf of a drug sponsor and (2) produces an end-user output that 
supplements, explains, or is otherwise textually related to one or more 
of the sponsor's drug products regardless of whether the software is 
regulated as a device \1\ under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act). A software function is a distinct purpose of the 
prescription drug use-related software, and end-user output is any 
material (content) that the prescription drug use-related software 
presents to the end user (e.g., a patient, caregiver, or health care 
practitioner). As discussed in this final guidance, FDA considers end-
user output to be a type of prescription drug labeling.
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    \1\ Under section 201(h)(1) of the Federal Food, Drug, and 
Cosmetic Act, ``the term `device' (except when used in paragraph (n) 
of this section and in sections 301(i), 403(f), 502(c), and 602(c)) 
means an instrument, apparatus, implement, machine, contrivance, 
implant, in vitro reagent, or other similar or related article, 
including any component, part, or accessory, which is--(A) 
recognized in the official National Formulary, or the United States 
Pharmacopeia, or any supplement to them, (B) intended for use in the 
diagnosis of disease or other conditions, or in the cure, 
mitigation, treatment, or prevention of disease, in man or other 
animals, or (C) intended to affect the structure or any function of 
the body of man or other animals, and which does not achieve its 
primary intended purposes through chemical action within or on the 
body of man or other animals and which is not dependent upon being 
metabolized for the achievement of its primary intended purposes. 
The term `device' does not include software functions excluded 
pursuant to section 520(o).''
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    This final guidance clarifies (1) how FDA intends to apply its drug 
labeling authorities to end-user output of prescription drug use-
related software, (2) how the FDA-required labeling, in particular the 
Prescribing Information (PI), should describe prescription drug use-
related software functions, and (3) when and how sponsors should submit 
end-user output to FDA for review. Generally, the recommendations 
provided in this final guidance are intended to align with ongoing 
Agency initiatives across all product centers, including digital health 
initiatives at the Center for Devices and Radiological Health. In 
developing this guidance, FDA has considered existing Agency policies 
to ensure consistent regulation of device software and efficient, 
coordinated review in instances when prescription drug use-related 
software is reviewed by the Agency as a device.
    This guidance finalizes the draft guidance titled ``Regulatory 
Considerations for Prescription Drug Use-Related Software'' issued on 
September 19, 2023 (88 FR 64443). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft to the final guidance include (1) clarifying the considerations 
for standalone software functions; (2) introducing a decision tree to 
guide sponsors through labeling determinations; (3) providing 
illustrative examples of PI language for both device-connected software 
and standalone software; and (4) recommending the addition of a 
statement in the PI for device-connected software functions for which 
there is no meaningful improvement in a clinical outcome. 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 ``Regulatory Considerations for Prescription 
Drug Use-Related Software.'' It does not establish any rights for any 
person and is not binding on FDA or the public.

[[Page 66563]]

You can use an alternative approach if it satisfies the requirements of 
the applicable statutes and regulations.
    FDA considered the applicability of Executive Order 14192, per OMB 
guidance in M-25-20, and finds this action to be neither an E.O. 14192 
regulatory action nor an E.O. 14192 deregulatory action.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 314 for new drug applications and abbreviated new drug 
applications have been approved under OMB control number 0910-0001. The 
collections of information in 21 CFR 601.2 and 601.12 for biologics 
license applications and supplemental applications have been approved 
under OMB control number 0910-0338. The collections of information in 
Form FDA 2253 have been approved under OMB control number 0910-0001. 
The collections of information for prescription drug product labeling 
requirements in 21 CFR 201.56 have been approved under OMB control 
number 0910-0572. The collections of information in 21 CFR 202.1 for 
prescription drug advertisements have been approved under OMB control 
number 0910-0686.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21516 Filed 10-20-26; 8:45 am]
BILLING CODE 4164-01-P


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