[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Notices]
[Pages 36133-36134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15344]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidances for Industry and Food and Drug Administration 
Staff: Classification of Products as Drugs and Devices and 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of two related draft guidances for industry and FDA staff 
entitled ``Draft Guidance for Industry and FDA Staff: Classification of 
Products as Drugs and Devices and Additional Product Classification 
Issues'' and ``Draft Guidance for Industry and FDA Staff: 
Interpretation of the Term 'Chemical Action' in the Definition of 
Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic 
Act.'' These draft guidances provide the Agency's current thinking on 
approaches for classifying products as drugs and devices, certain 
additional product classification issues, and the interpretation of the 
term ``chemical action'' under the FD&C Act.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
these draft guidances before it begins work on the final versions of 
these guidances, submit either electronic or written comments on the 
draft guidances by September 19, 2011.

ADDRESSES: Submit written requests for single copies of these draft 
guidances to the Office of Combination Products, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive

[[Page 36134]]

label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit electronic comments on the draft guidances to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of two draft guidances for 
industry and FDA staff entitled ``Draft Guidance for Industry and FDA 
Staff: Classification of Products as Drugs and Devices and Additional 
Product Classification Issues'' (Draft Classification Guidance) and 
``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 
'Chemical Action' in the Definition of Device Under Section 201(h) of 
the Federal Food, Drug, and Cosmetic Act'' (Draft Chemical Action 
Guidance). These draft guidances provide the Agency's current thinking 
on approaches for classifying products as drugs and devices, certain 
additional product classification issues, and the interpretation of the 
term ``chemical action'' under section 201(h).
    FDA determines whether to classify a product as a drug or device 
based on the statutory definitions for these terms set forth in 
sections 201(g) and 201(h) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act)(21 U.S.C. 321(g) and 321(h)), respectively, as applied 
to the scientific data concerning the product that are available to FDA 
at the time the classification determination is made.
    The Draft Classification Guidance addresses three topics: (1) It 
explains how to obtain a formal classification determination for a 
medical product; (2) it presents the Agency's current thinking on the 
interpretation of the statutory definitions of device and drug, other 
than the term ``chemical action'' in the definition of device at 
section 201(h), which is addressed in the Draft Chemical Action 
Guidance, as discussed in the following paragraphs; and (3) it presents 
the Agency's current thinking on the status of published intercenter 
jurisdictional agreements, current regulations establishing 
classifications, and classifications the Agency has otherwise 
previously made for specific products.
    The definition of device at section 201(h) states, in part, that a 
device ``does not achieve its primary intended purposes through 
chemical action within or on the body of man or other animals.'' The 
term ``chemical action'' in this phrase is often important in 
determining whether a product meets the definition of device at section 
201(h). The Draft Chemical Action Guidance presents the Agency's 
current thinking on the interpretation of the term ``chemical action'' 
for purposes of this definition. The Draft Chemical Action Guidance 
states that a product exhibits chemical action if: ``through either 
chemical reaction or intermolecular forces or both, the product 
mediates a bodily response at the cellular or molecular level, or 
combines with or modifies an entity so as to alter that entity's 
interaction with the body of man or other animals.''
    The Agency welcomes all comments on the Draft Classification 
Guidance and the Draft Chemical Action Guidance. In particular, we 
request comment on the following two topics:
    1. Application of the approaches articulated in these two draft 
guidances to specific groups of products.
    We seek input on how groups of products would be classified under 
these approaches and the regulatory implications of those 
classifications. While we welcome more general input on the approaches 
announced, we are seeking particular comments regarding the application 
of these approaches to specific products or groups of products. We note 
that questions concerning whether to classify a product as a drug or 
device have most frequently arisen with respect to products consisting 
of gels, liquids, semi-liquids, or powders that come into contact with 
the body.
    We also seek input on whether or how to clarify or modify any 
elements or terms of the approaches presented. For example, the 
approach for whether a product exhibits chemical action quoted 
previously from the Draft Chemical Action Guidance includes the phrase 
``mediates a bodily response at the cellular or molecular level.'' We 
welcome input on this phrase or any other aspect of this approach.
    2. Relationship between these classification approaches and prior 
classification determinations.
    As noted previously, the Draft Classification Guidance discusses 
the Agency's current thinking on the status of the current published 
intercenter jurisdictional agreements, regulations establishing 
classifications, and other classifications of specific products (e.g., 
via marketing authorizations or requests for designation). We seek 
comment on the concepts presented in this section of the Draft 
Classification Guidance. For example, we welcome comment on procedures 
for determining whether to change current product classifications and, 
if so, how to implement those changes appropriately.
    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). These draft guidances, 
when finalized, will represent the Agency's current thinking on 
classification of products as drugs and devices, certain additional 
product classification issues, and the interpretation of the term 
``chemical action'' under section 201(h). They do not create or confer 
any rights for or on any person and do not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.
    The draft guidance on classification of products as drugs or 
devices 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding these 
documents. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15344 Filed 6-20-11; 8:45 am]
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