Notice2024-14409
Essential Drug Delivery Outputs for Devices Intended To Deliver Drugs and Biological Products; Draft Guidance for Industry; Availability
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Published
July 1, 2024
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products."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.
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<title>Federal Register, Volume 89 Issue 126 (Monday, July 1, 2024)</title>
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[Federal Register Volume 89, Number 126 (Monday, July 1, 2024)]
[Notices]
[Pages 54470-54471]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-14409]
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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Drugs and Biological Products; Draft Guidance for Industry;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.
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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the availability of a draft guidance for industry entitled ``Essential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:
<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 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 <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 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,
<a href="/cdn-cgi/l/email-protection#feae9f8a8c979d979fd0b291889bbe989a9fd096968dd0999188"><span class="__cf_email__" data-cfemail="74241500061d171d155a381b0211341210155a1c1c075a131b02">[email protected]</span></a> or <a href="/cdn-cgi/l/email-protection#fd9e92909f94939c89949293bd9b999cd39a928b"><span class="__cf_email__" data-cfemail="5e3d31333c37303f2a3731301e383a3f70393128">[email protected]</span></a>.
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 <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: 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
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