[Federal Register Volume 89, Number 126 (Monday, July 1, 2024)]
[Notices]
[Pages 54470-54471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14409]



[[Page 54470]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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Drugs and Biological Products; Draft Guidance for Industry; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Essential 
Drug Delivery Outputs for Devices Intended to Deliver Drugs and 
Biological Products.'' 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). The guidance describes FDA's recommendations related 
to the device design outputs that are essential for establishing and 
assessing drug delivery performance. FDA is providing recommendations 
for development and organization of device drug-delivery performance 
information to improve the consistency of this information in 
applications and submissions. The guidance is intended to facilitate 
and streamline development of drug delivery devices.

DATES: Submit either electronic or written comments on the draft 
guidance by September 30, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-2024-D-2560 for ``Essential Drug Delivery Outputs 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 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 the 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 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, 
[email protected] or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Essential Drug Delivery Outputs for Devices Intended to 
Deliver Drugs and Biological Products.'' 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). The guidance describes FDA's 
recommendations related to the device design outputs that are essential 
for establishing and assessing drug delivery performance. Device drug-
delivery performance information is intended to demonstrate that the 
device drug-delivery function consistently performs as intended. As 
discussed further in the guidance, essential drug delivery output 
(EDDO) refers to the device drug-delivery design outputs necessary to 
ensure the drug delivery function.

[[Page 54471]]

    This guidance recommends an approach to identifying EDDOs, provides 
examples of EDDOs for specific types of devices, and describes the 
information and data related to EDDOs that is provided in an 
application or submission. Examples of products that are within the 
scope of this guidance include syringes, injectors (e.g., autoinjector, 
on body injector), infusion products (e.g., infusion pumps), nasal 
sprays, inhalers, nebulizers, and vaginal systems.
    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 ``Essential 
Drug Delivery Outputs 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.

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 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 OMB control number 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 OMB control 
number 0910-0718. The collections of information in 21 CFR part 814 for 
premarket approval applications have been approved under OMB control 
number 0910-0231. The collections of information in section 510(k) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)), subpart E 
for 510(k) 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 system regulation have 
been approved under OMB control number 0910-0073. The collections of 
information in 21 CFR part 807, subpart E for premarket notification 
have been approved under OMB control number 0910-0120. The collections 
of information for meetings 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 draft 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: June 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-14409 Filed 6-28-24; 8:45 am]
BILLING CODE 4164-01-P