82_FR_44987 82 FR 44802 - Classification of Products as Drugs and Devices and Additional Product Classification Issues; Guidance for Industry and Food and Drug Administration Staff; Availability

82 FR 44802 - Classification of Products as Drugs and Devices and Additional Product Classification Issues; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 185 (September 26, 2017)

Page Range44802-44803
FR Document2017-20522

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.

Federal Register, Volume 82 Issue 185 (Tuesday, September 26, 2017) 
[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44802-44803]
From the Federal Register Online  [www.thefederalregister.org]
[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:
     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-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.
     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.thefederalregister.org/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

44802 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices Dated: September 19, 2017. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- Lance Robertson, public, submit the comment as a 23389.pdf. Administrator and Assistant Secretary for written/paper submission and in the Docket: For access to the docket to Aging. manner detailed (see ‘‘Written/Paper read background documents or the [FR Doc. 2017–20460 Filed 9–25–17; 8:45 am] Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments BILLING CODE 4154–01–P Written/Paper Submissions received, go to https:// www.regulations.gov and insert the Submit written/paper submissions as docket number, found in brackets in the DEPARTMENT OF HEALTH AND follows: heading of this document, into the HUMAN SERVICES • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts written/paper submissions): Dockets and/or go to the Dockets Management Food and Drug Administration Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, [Docket No. FDA–2011–D–0429] Drug Administration, 5630 Fishers Rockville, MD 20852. Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any Classification of Products as Drugs • For written/paper comments guidance at any time (see 21 CFR and Devices and Additional Product submitted to the Dockets Management 10.115(g)(5)). Classification Issues; Guidance for Staff, FDA will post your comment, as Submit written requests for single Industry and Food and Drug well as any attachments, except for copies of the guidance document Administration Staff; Availability information submitted, marked and entitled ‘‘Classification of Products as identified, as confidential, if submitted Drugs and Devices & Additional Product AGENCY: Food and Drug Administration, as detailed in ‘‘Instructions.’’ Classification Issues’’ to the Office of HHS. Instructions: All submissions received Combination Products, Food and Drug ACTION: Notice of availability. must include the Docket No. FDA– Administration, 10903 New Hampshire SUMMARY: The Food and Drug 2011–D–0429 for ‘‘Classification of Ave., Bldg. 32, Rm. 5129, Silver Spring, Administration (FDA or Agency) is Products as Drugs and Devices & MD 20993–0002. Send one self- announcing the availability of a final Additional Product Classification addressed adhesive label to assist that guidance for industry and FDA staff Issues.’’ Received comments will be office in processing your request. See entitled ‘‘Classification of Products as placed in the docket and, except for the SUPPLEMENTARY INFORMATION section Drugs and Devices & Additional Product those submitted as ‘‘Confidential for electronic access to the guidance Classification Issues.’’ This guidance Submissions,’’ publicly viewable at document. provides the Agency’s current thinking https://www.regulations.gov or at the Dockets Management Staff office FOR FURTHER INFORMATION CONTACT: John on approaches for classifying products between 9 a.m. and 4 p.m., Monday Barlow Weiner, Associate Director for as drugs and devices, and on certain Policy, Office of Combination Products, additional product classification issues. through Friday. • Confidential Submissions—To Food and Drug Administration, 10903 DATES: The announcement of the submit a comment with confidential New Hampshire Ave., Bldg. 32, Rm. guidance is published in the Federal 5129, Silver Spring, MD 20993–0002, Register on September 26, 2017. information that you do not wish to be made publicly available, submit your 301–796–8930. ADDRESSES: You may submit either comments only as a written/paper SUPPLEMENTARY INFORMATION: electronic or written comments on Agency guidances at any time as submission. You should submit two I. Background follows: copies total. One copy will include the information you claim to be confidential FDA is announcing the availability of Electronic Submissions with a heading or cover note that states a guidance for industry and FDA staff Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS entitled ‘‘Classification of Products as following way: CONFIDENTIAL INFORMATION.’’ The Drugs and Devices & Additional Product • Federal eRulemaking Portal: https:// Agency will review this copy, including Classification Issues.’’ This guidance www.regulations.gov. Follow the the claimed confidential information, in finalizes two related draft guidance instructions for submitting comments. its consideration of comments. The documents issued in June 2011, entitled Comments submitted electronically, second copy, which will have the ‘‘Classification of Products as Drugs and including attachments, to https:// claimed confidential information Devices & Additional Product www.regulations.gov will be posted to redacted/blacked out, will be available Classification Issues’’ and the docket unchanged. Because your for public viewing and posted on ‘‘Interpretation of the Term ’Chemical comment will be made public, you are https://www.regulations.gov. Submit Action’ in the Definition of Device solely responsible for ensuring that your both copies to the Dockets Management under Section 201(h) of the Federal comment does not include any Staff. If you do not wish your name and Food, Drug, and Cosmetic Act.’’ confidential information that you or a contact information to be made publicly This guidance is intended to provide third party may not wish to be posted, available, you can provide this the Agency’s current thinking on such as medical information, your or information on the cover sheet and not approaches for classifying products as anyone else’s Social Security number, or in the body of your comments and you drugs and devices, and on certain confidential business information, such must identify this information as additional product classification issues. as a manufacturing process. Please note ‘‘confidential.’’ Any information marked FDA determines whether to classify a that if you include your name, contact as ‘‘confidential’’ will not be disclosed product as a drug or device based on the information, or other information that except in accordance with 21 CFR 10.20 statutory definitions for these terms set identifies you in the body of your and other applicable disclosure law. For forth in section 201(g) and (h) of the comments, that information will be more information about FDA’s posting Federal Food, Drug, and Cosmetic Act posted on https://www.regulations.gov. of comments to public dockets, see 80 (the FD&C Act) (21 U.S.C. 321(g) and • If you want to submit a comment FR 56469, September 18, 2015, or access (h)), respectively, as applied to the with confidential information that you the information at: https://www.gpo.gov/ scientific data concerning the products VerDate Sep<11>2014 18:28 Sep 25, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 44803 that are available to FDA at the time the continue to address the issue on a case- SUMMARY: The Food and Drug classification determination is made. by-case, fact-specific basis as needed, in Administration (FDA or the Agency) is FDA regularly receives questions from a transparent manner as permitted by, announcing a public hearing on a medical product sponsors concerning and consistent with, applicable legal potential approach for device sponsors the classification of their products. We requirements. Any stakeholder who has who seek to obtain marketing believe that efficient, effective questions regarding the classification of authorization for their products that are regulation would be facilitated by a currently marketed product or labeled for a new use with an approved, providing guidance on this topic. This whether that classification should be marketed drug when the sponsor for the guidance discusses the request for relied upon with respect to a proposed approved drug does not wish to pursue designation (RFD) process for obtaining product is encouraged to contact the or collaborate on the new use. a formal determination of a product’s Office of Combination Products. DATES: The public hearing will be held classification, and provides general on November 16, 2017, from 9 a.m. to concepts regarding FDA’s decision II. Significance of Guidance 5 p.m. The public hearing may be process for making classification This guidance is being issued extended or may end early depending determinations. While issues have consistent with FDA’s good guidance on the level of public participation. arisen relating to whether a product practices regulation (21 CFR 10.115). Persons seeking to attend or to present should be classified as a drug, device, The guidance represents the current at the public hearing must register by biological product, or combination thinking of FDA on ‘‘Classification of October 26, 2017. Sections II and III product, issues most frequently arise Products as Drugs and Devices & provides attendance and registration regarding whether a product should be Additional Product Classification information. Electronic or written classified as either a drug or a device. Issues.’’ It does not establish any rights comments will be accepted after the Accordingly, this guidance focuses for any person and is not binding on public hearing until January 15, 2018. particularly on cases in which a product FDA or the public. You can use an Late, untimely filed comments will not may be classified as a drug or device. alternative approach if it satisfies the This guidance is organized into two be considered. requirements of the applicable statutes substantive sections. Section II provides ADDRESSES: The public hearing will be and regulations. This guidance is not information on the RFD process for held at the FDA White Oak Campus, subject to Executive Order 12866. obtaining a formal determination of 10903 New Hampshire Ave., Building whether a product is classified as a drug III. Paperwork Reduction Act of 1995 31 Conference Center, the Great Room or device and on obtaining other This guidance refers to previously (Rm. 1503, Section A), Silver Spring, feedback from FDA on product approved collections of information MD 20993–0002. Entrance for the public classification questions. Section III found in FDA regulations. These hearing participants (non-FDA discusses general concepts and collections of information are subject to employees) is through Building 1, where definitions relating to FDA’s decisional review by the Office of Management and routine security check procedures will process for making classification Budget (OMB) under the Paperwork be performed. For parking and security determinations and addresses issues Reduction Act of 1995 (44 U.S.C. 3501– information, please refer to https:// that may arise in determining whether 3520). The collections of information in www.fda.gov/AboutFDA/Working products should be classified as drugs 21 CFR part 3 have been approved atFDA/BuildingsandFacilities/White or devices. under OMB control number 0910–0523. OakCampusInformation/ FDA carefully considered the ucm241740.htm. comments received on the two draft IV. Electronic Access Electronic Submissions guidances in preparing this final Persons with access to the internet guidance. We have combined the two Submit electronic comments in the may obtain the document at https:// documents into one and made other following way: www.fda.gov/RegulatoryInformation/ changes for clarity and ease of reference. • Federal eRulemaking Portal: Guidances/ucm258946.htm. For example, we have revised the https://www.regulations.gov. Follow the discussion of the Agency’s Dated: September 21, 2017. instructions for submitting comments. interpretation and application of the Anna K. Abram, Comments submitted electronically, term ‘‘chemical action’’ in the definition Deputy Commissioner for Policy, Planning, including attachments, to https:// of device at section 201(h) of the FD&C Legislation, and Analysis. www.regulations.gov will be posted to Act, to more clearly explain the [FR Doc. 2017–20522 Filed 9–25–17; 8:45 am] the docket unchanged. Because your Agency’s approach. With regard to this BILLING CODE 4164–01–P comment will be made public, you are issue and others, we have also included solely responsible for ensuring that your additional examples to illustrate the comment does not include any application of the Agency’s current DEPARTMENT OF HEALTH AND confidential information that you or a thinking. HUMAN SERVICES third party may not wish to be posted, In light of comments received, we such as medical information, your or have also reconsidered inclusion of Food and Drug Administration anyone else’s Social Security number, or content on the status of prior Agency confidential business information, such classification determinations. FDA has [Docket No. FDA–2017–N–5319] as a manufacturing process. Please note had limited experience with that if you include your name, contact reevaluating classification Devices Proposed for a New Use With information, or other information that determinations as the issue rarely arises an Approved, Marketed Drug; Public identifies you in the body of your for FDA to consider. In addition, it can Hearing; Request for Comments comments, that information will be raise a variety of complex scientific and AGENCY: Food and Drug Administration, posted on https://www.regulations.gov. regulatory questions. Accordingly, we HHS. • If you want to submit a comment have concluded that it is not with confidential information that you ACTION: Notification of public hearing; appropriate to address the topic further do not wish to be made available to the request for comments. in guidance at this time. We will public, submit the comment as a VerDate Sep<11>2014 18:28 Sep 25, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1


Document Created: 2017-09-26 02:49:05
Document Modified: 2017-09-26 02:49:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on September 26, 2017.
ContactJohn 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.
FR Citation82 FR 44802 
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