Document ID: FDA-2019-D-0078-0014
Agency: fda
Document Type: Notice
Title: Principles of Premarket Pathways for Combination Products; Guidance for Industry and Food and Drug
Administration Staff; Availability
Posted Date: 2022-01-31T05:00Z

[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4895-4897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01925]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0078]

Principles of Premarket Pathways for Combination Products; 
Guidance for Industry and Food and Drug Administration 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 ``Principles of Premarket Pathways for Combination Products.'' 
This guidance presents FDA's current thinking on principles for 
premarket review of combination products. This guidance includes 
general, high-level information regarding what combination products 
are, coordination within FDA and interaction between FDA and sponsors 
regarding combination product regulation, and how combination products 
are reviewed by FDA before

[[Page 4896]]

they are marketed. The guidance also includes recommendations on how to 
determine which type of premarket submissions may be appropriate for 
combination products. FDA is publishing this guidance as part of its 
efforts to implement the 21st Century Cures Act (Cures Act) and in 
keeping with the Agency's long-standing commitment to transparency, 
efficiency, and regulatory consistency to facilitate development of 
safe and effective combination products. This guidance finalizes the 
draft guidance of the same title that published on February 6, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on January 31, 2022.

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-2019-D-0078 for ``Principles of Premarket Pathways for Combination 
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 this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of 
Combination Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 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 ``Principles of Premarket Pathways for Combination 
Products.'' This guidance presents FDA's current thinking on principles 
for premarket review of combination products. This guidance includes 
general, high-level information regarding what combination products 
are, coordination within FDA and interaction between FDA and sponsors 
regarding combination product regulation, and how combination products 
are reviewed by FDA before they are marketed. The guidance also 
includes recommendations on how to determine which type of premarket 
submissions may be appropriate for combination products, as well as 
illustrative examples.
    Section 3038 of the Cures Act (Pub. L. 114-255), enacted in 
December 2016, substantially amended section 503(g) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353(g)), the 
principal section of the FD&C Act expressly addressing combination 
products. General themes of these amendments include enhancing clarity, 
predictability, efficiency, and consistency of premarket regulatory 
expectations for combination products, including by ensuring that 
Agency components and staff coordinate appropriately on premarket 
review of these products, and that Agency thinking is aligned in 
conducting these reviews. This guidance is part of FDA's efforts to 
implement section 3038 of the Cures Act.
    In the Federal Register of February 6, 2019 (84 FR 2236), FDA 
announced the availability of the draft guidance of the same title. FDA 
received comments and considered those comments as the guidance was 
finalized. The final guidance clarifies the guidance including its 
applicability across combination product types and additional detail 
regarding processes for interacting with the Agency.

[[Page 4897]]

    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 ``Principles of Premarket Pathways for 
Combination 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. 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 3 and in the guidance ``How to Prepare a 
Pre-Request for Designation (Pre-RFD)'' have been approved under OMB 
control number 0910-0523. The collections of information for 
applications for FDA approval to market a new drug (certain provisions 
of 21 CFR part 314) have been approved under OMB control number 0910-
0001; the collections of information in 21 CFR part 601 have been 
approved under 0910-0338; and the collections of information in section 
351(k) of the Public Health Service Act (42 U.S.C. 262) have been 
approved under 0910-0719. The collections of information in 21 CFR part 
807, subpart E, have been approved under OMB control number 0910-0120; 
the collections of information in 21 CFR part 814, subparts A through 
E, have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 860, subparts A through C, 
have been approved under OMB control number 0910-0138; the collections 
of information in the guidance document ``Requests for Feedback and 
Meetings for Medical Device Submissions: The Q-Submission Program'' 
have been approved under OMB control number 0910-0756; and the 
collections of information in 21 CFR part 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: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01925 Filed 1-28-22; 8:45 am]
BILLING CODE 4164-01-P