[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44802-44803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0429]


Classification of Products as Drugs and Devices and Additional 
Product Classification Issues; 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 ``Classification of Products as Drugs and Devices & Additional 
Product Classification Issues.'' This guidance provides the Agency's 
current thinking on approaches for classifying products as drugs and 
devices, and on certain additional product classification issues.

DATES: The announcement of the guidance is published in the Federal 
Register on September 26, 2017.

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: 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.
    <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-2011-D-0429 for ``Classification of Products as Drugs and Devices & 
Additional Product Classification Issues.'' 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 office between 9 a.m. and 4 p.m., Monday 
through Friday.
    <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 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.gpo.gov/fdsys/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.
    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 guidance document 
entitled ``Classification of Products as Drugs and Devices & Additional 
Product Classification Issues'' 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 request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Associate Director 
for Policy, Office of Combination Products, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver 
Spring, MD 20993-0002, 301-796-8930.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Classification of Products as Drugs and Devices & 
Additional Product Classification Issues.'' This guidance finalizes two 
related draft guidance documents issued in June 2011, entitled 
``Classification of Products as Drugs and Devices & Additional Product 
Classification Issues'' and ``Interpretation of the Term 'Chemical 
Action' in the Definition of Device under Section 201(h) of the Federal 
Food, Drug, and Cosmetic Act.''
    This guidance is intended to provide the Agency's current thinking 
on approaches for classifying products as drugs and devices, and on 
certain additional product classification issues. FDA determines 
whether to classify a product as a drug or device based on the 
statutory definitions for these terms set forth in section 201(g) and 
(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 
U.S.C. 321(g) and (h)), respectively, as applied to the scientific data 
concerning the products

[[Page 44803]]

that are available to FDA at the time the classification determination 
is made.
    FDA regularly receives questions from medical product sponsors 
concerning the classification of their products. We believe that 
efficient, effective regulation would be facilitated by providing 
guidance on this topic. This guidance discusses the request for 
designation (RFD) process for obtaining a formal determination of a 
product's classification, and provides general concepts regarding FDA's 
decision process for making classification determinations. While issues 
have arisen relating to whether a product should be classified as a 
drug, device, biological product, or combination product, issues most 
frequently arise regarding whether a product should be classified as 
either a drug or a device. Accordingly, this guidance focuses 
particularly on cases in which a product may be classified as a drug or 
device.
    This guidance is organized into two substantive sections. Section 
II provides information on the RFD process for obtaining a formal 
determination of whether a product is classified as a drug or device 
and on obtaining other feedback from FDA on product classification 
questions. Section III discusses general concepts and definitions 
relating to FDA's decisional process for making classification 
determinations and addresses issues that may arise in determining 
whether products should be classified as drugs or devices.
    FDA carefully considered the comments received on the two draft 
guidances in preparing this final guidance. We have combined the two 
documents into one and made other changes for clarity and ease of 
reference. For example, we have revised the discussion of the Agency's 
interpretation and application of the term ``chemical action'' in the 
definition of device at section 201(h) of the FD&C Act, to more clearly 
explain the Agency's approach. With regard to this issue and others, we 
have also included additional examples to illustrate the application of 
the Agency's current thinking.
    In light of comments received, we have also reconsidered inclusion 
of content on the status of prior Agency classification determinations. 
FDA has had limited experience with reevaluating classification 
determinations as the issue rarely arises for FDA to consider. In 
addition, it can raise a variety of complex scientific and regulatory 
questions. Accordingly, we have concluded that it is not appropriate to 
address the topic further in guidance at this time. We will continue to 
address the issue on a case-by-case, fact-specific basis as needed, in 
a transparent manner as permitted by, and consistent with, applicable 
legal requirements. Any stakeholder who has questions regarding the 
classification of a currently marketed product or whether that 
classification should be relied upon with respect to a proposed product 
is encouraged to contact the Office of Combination Products.

II. Significance of Guidance

    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 ``Classification of Products as Drugs and 
Devices & Additional Product Classification Issues.'' 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. This guidance 
is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 3 have been approved under 
OMB control number 0910-0523.

IV. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.htm.

    Dated: September 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20522 Filed 9-25-17; 8:45 am]
 BILLING CODE 4164-01-P