Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products." This revised draft guidance revises and replaces the draft guidance entitled "Essential Drug Delivery Outputs Intended to Deliver Drugs and Biological Products" announced in the Federal Register on July 1, 2024 (89 FR 54470). In accordance with its mission of protecting, promoting, and advancing public health, this guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product (herein referred to as drug delivery devices). This guidance provides recommendations for development and organization of device drug-delivery performance information and data to improve the consistency of this information in applications and to facilitate transparency and predictability in development and regulatory review. The guidance is intended to facilitate and streamline development and lifecycle management of drug delivery devices.

Full Text

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<title>Federal Register, Volume 91 Issue 209 (Friday, October 30, 2026)</title>
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[Federal Register Volume 91, Number 209 (Friday, October 30, 2026)]
[Notices]
[Pages 68523-68525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22203]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2560]


Essential Drug Delivery Performance Characteristics for Devices 
Intended To Deliver Drugs and Biological Products; Revised Draft 
Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled 
``Essential Drug Delivery Performance Characteristics for Devices 
Intended to Deliver Drugs and Biological Products.'' This revised draft 
guidance revises and replaces the draft guidance entitled ``Essential 
Drug Delivery Outputs Intended to Deliver Drugs and Biological 
Products'' announced in the Federal Register on July 1, 2024 (89 FR 
54470). In accordance with its mission of protecting, promoting, and 
advancing public health, this guidance addresses key aspects of drug 
delivery performance information for devices, and combination products 
that include device constituent parts, intended for delivery of a human 
drug, including a biological product (herein referred to as drug 
delivery devices). This guidance provides recommendations for 
development and organization of device drug-delivery performance 
information and data to improve the consistency of this information in 
applications and to facilitate transparency and predictability in 
development and regulatory review. The guidance is intended to 
facilitate and streamline development and lifecycle management of drug 
delivery devices.

DATES: Submit either electronic or written comments on the revised 
draft guidance by January 28, 2027 to ensure that the Agency considers 
your comment on this revised draft guidance before it begins work on 
the final version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2024-D-2560 for ``Essential Drug Delivery Performance 
Characteristics for Devices Intended to Deliver Drugs and Biological 
Products.'' 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

[[Page 68524]]

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 the revised draft 
guidance to the Office of 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 revised draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Patricia Love, Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5129, Silver Spring, MD 20993, 301-796-8930, 
<a href="/cdn-cgi/l/email-protection#0171607573686268602f6d6e7764416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="3848594c4a515b51591654574e5d785e5c591650504b165f574e">[email&#160;protected]</span></a> or <a href="/cdn-cgi/l/email-protection#6a0905070803040b1e0305042a0c0e0b440d051c"><span class="__cf_email__" data-cfemail="0665696b646f6867726f69684660626728616970">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Essential Drug Delivery Performance Characteristics 
for Devices Intended to Deliver Drugs and Biological Products.'' This 
revised draft guidance revises and replaces the draft guidance entitled 
``Essential Drug Delivery Outputs Intended to Deliver Drugs and 
Biological Products'' announced on July 1, 2024 (89 FR 54470). This 
guidance provides updates to clarify content on testing and controlling 
device drug-delivery performance and to align with the revised Quality 
Management System Regulation, 21 CFR part 820.
    The guidance describes FDA's recommendations related to information 
that is essential for establishing and assessing drug delivery 
performance for drug delivery devices. Device drug-delivery performance 
information is intended to demonstrate that the device drug-delivery 
function consistently performs as intended. The guidance focuses on 
recommendations for the information and data to submit in 
investigational, marketing, and post-market change applications.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidance, when finalized, will represent the current thinking of FDA on 
``Essential Drug Delivery Performance Characteristics for Devices 
Intended to Deliver Drugs and Biological Products.'' 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.
    As we develop final guidance on this topic, FDA will consider 
comments on costs or cost savings the guidance may generate, relevant 
for Executive Order 14192.

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 in 21 CFR part 312 for investigational new drug 
applications have been approved under OMB control number 0910-0014 and 
the collections of information in 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 and abbreviated new drug applications, including the 
collections of information contained in the guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants 
of PDUFA Products'' have been approved under OMB control number 0910-
0001. The collections of information in 21 CFR parts 601 and 610 for 
biologics license applications have been approved under 0910-0338. The 
collections of information in section 351(k) of the Public Health 
Service Act (42 U.S.C. 262(k)) have been approved under 0910-0718. The 
collections of information in 21 CFR part 814 for premarket approval 
applications have been approved under 0910-0231. The collections of 
information in section 510(k) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(k)), 21 CFR part 807, subpart E for premarket 
notifications, have been approved under OMB control number 0910-0120. 
The collections of information in 21 CFR 860, subpart D for De Novo 
classifications have been approved under OMB control number 0910-0844. 
The collections of information in 21 CFR part 211 for current good 
manufacturing practice for finished pharmaceuticals have been approved 
under OMB control number 0910-0139. The collections of information in 
21 CFR part 820 for the quality management system regulation have been 
approved under OMB control number 0910-0073. The collections of 
information for meetings and controlled correspondence related to 
generic drug development have been approved under OMB control number 
0910-0727. The collections of information in the guidance for industry 
and FDA staff entitled ``Requests for Feedback on Medical Device 
Submissions: The Q-Submission Program and Meetings with the Food and 
Drug Administration Staff'' have been approved under OMB control number 
0910-0756.

III. Electronic Access

    Persons with access to the internet may obtain the revised draft 
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>, https:/
/www.fda.gov/regulatory-information/

[[Page 68525]]

search-fda-guidance-documents 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. 2026-22203 Filed 10-29-26; 8:45 am]
BILLING CODE 4164-01-P


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