Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Referencing the Definition of “Device”
in the Federal Food, Drug, and
Cosmetic Act in Guidance, Regulatory
Documents, Communications, and
Other Public Documents
______________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
Document issued on November 14, 2022.
The draft of this document was issued on December 16, 2021.
For questions about this document regarding CDRH-regulated devices, contact the CDRH
Guidance Program in the Office of Policy at CDRH-Guidance@fda.hhs.gov. For questions about
this document regarding CBER-regulated devices, contact the Office of Communication, Outreach,
and Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2021-D-0997. Comments may not be acted
upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number
21008 and complete title of the guidance in the request.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
8010, by email, ocod@fda.hhs.gov, or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

Contains Nonbinding Recommendations
Table of Contents
I. Introduction ............................................................................................................................. 1
II. Background ............................................................................................................................. 1
III. Scope ....................................................................................................................................... 2
IV. Policy ...................................................................................................................................... 3
Existing References to Section 201(h) of the FD&C Act and the Term “Device”.......... 3
Future References to the Term “Device” ......................................................................... 4
References to the Term “Device” in Documents FDA Receives..................................... 5

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Referencing the Definition of “Device”
in the Federal Food, Drug, and
Cosmetic Act in Guidance, Regulatory
Documents, Communications, and
Other Public Documents
______________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. 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. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.
I. Introduction
The U.S. Food and Drug Administration (FDA or the Agency) recommends the consistent use of
terms and definitions of legal significance. In light of recent amendments to section 201(h) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) as a result of the enactment of the
Safeguarding Therapeutics Act,1 FDA is issuing this guidance to promote clarity regarding
references to the terms “device” and “counterfeit device.”
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. Background
For many years, the definition of “device” has been codified at section 201(h) of the FD&C Act.
Upon enactment of the Safeguarding Therapeutics Act, the definition of “device” was
1 Pub. L. 116-304, 134 Stat. 4915.

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redesignated as paragraph (1) of subsection (h) and a new definition of “counterfeit device” was
codified at paragraph (2) of subsection (h). In its entirety, section 201(h) of the FD&C Act now
reads:
(h)(1) The term “device” (except when used in paragraph (n) of this section and in
sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, which is—
(A) recognized in the official National Formulary, or the United States
Pharmacopeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other
animals, and
which does not achieve its primary intended purposes through chemical action within or
on the body of man or other animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes. The term “device” does not include
software functions excluded pursuant to section 520(o).
(2) The term “counterfeit device” means a device which, or the container, packaging, or
labeling of which, without authorization, bears a trademark, trade name, or other
identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of
a device manufacturer, processor, packer, or distributor other than the person or persons
who in fact manufactured, processed, packed, or distributed such device and which
thereby falsely purports or is represented to be the product of, or to have been packed or
distributed by, such other device manufacturer, processor, packer, or distributor.
III. Scope
The Safeguarding Therapeutics Act adds and defines a new term: “counterfeit device” (section
201(h)(2) of the FD&C Act).2 It also redesignates the definition of “device” (section 201(h)(1) of
the FD&C Act).3 It does not make any changes to the existing “device” definition.
In addition, under the Safeguarding Therapeutics Act, articles that appear to be counterfeit
devices are subject to refusal of admission into the United States.4 The Safeguarding
Therapeutics Act also grants FDA new authority to destroy certain devices refused admission.5
These additional amendments to the FD&C Act are being implemented through separate policy
documents and are beyond the scope of this guidance.
FDA is issuing this guidance to clarify how the Agency interprets existing references to section
201(h) of the FD&C Act and how we intend to reference the definitions of “device” and
2 Pub. L. 116-304, section 2(b), 134 Stat. 4916, amending section 201(h) of the FD&C Act.
3 Id.
4 Pub. L. 116-304, section 2(a), 134 Stat. 4915, amending section 801(a) of the FD&C Act.
5 Id.

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“counterfeit device” going forward. This guidance is intended to provide clarity on references to
the terms “device” and “counterfeit device” – as well as references to section 201(h) of the
FD&C Act – in guidance, regulatory documents, and other communications and documents for
FDA staff, industry, and other stakeholders.
IV. Policy
Existing References to Section 201(h) of the FD&C Act
and the Term “Device”
In statutes, regulations, guidance, other statements of policy, judicial filings, warning letters,
untitled letters, and many other public documents, there are specific references to the term
“device” as that term is defined in section 201(h) of the FD&C Act. For example, the Public
Readiness and Emergency Preparedness (PREP) Act defines a “covered countermeasure” to
include a “device (as such term is defined by section 201(h) of the Federal Food, Drug and
Cosmetic Act) . . .”.6 In these instances, FDA understands that the intent – whether
Congressional, Agency, or otherwise – was to refer to the definition of “device” that was
codified at section 201(h) of the FD&C Act at the time the reference was made (as discussed
above, the definition of “device” is now codified at section 201(h)(1) as a result of the enactment
of the Safeguarding Therapeutics Act).
When the purpose of the reference to section 201(h) of the FD&C Act is to define or refer to the
term “device,” there should be no ambiguity about which term is being referenced. The “device”
definition remains within subsection (h).
Any existing references made to section 201(h) of the FD&C Act in FDA policy documents,
including enforcement policies that describe FDA’s intent not to enforce certain requirements
under the FD&C Act, are not intended to apply to counterfeit devices. For example, in our
guidance “Policy for Device Software Functions and Mobile Medical Applications,”7 we
announced an enforcement policy that describes the circumstances in which FDA generally
intends to exercise enforcement discretion (meaning FDA does not intend to enforce certain
requirements of the FD&C Act) for certain software functions that meet the definition of
“device” as defined in section 201(h) of the FD&C Act. Although counterfeit devices may
themselves meet the definition of “device,” it was not FDA’s intent to exercise enforcement
discretion or otherwise extend certain policies to counterfeit devices.8
6 42 U.S.C. 247d–6d(i)(1)(C).
7 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-
functions-and-mobile-medical-applications.
8 Products that meet the definition of a “counterfeit device” under section 201(h)(2) of the FD&C Act would
generally be in violation of the FD&C Act, e.g., would be deemed misbranded under section 502 of the FD&C Act.
Further, as discussed above, the Safeguarding Therapeutics Act amended section 801(a) of the FD&C Act to make
clear that counterfeit devices (as defined in section 201(h)(2)) are subject to refusal of admission into the United
States. Additionally, counterfeit devices may be harmful to health. Consequently, FDA’s enforcement policies
applicable to devices that describe FDA’s intent not to enforce certain requirements of the FD&C Act do not apply
to counterfeit devices.

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Future References to the Term “Device”
Following enactment of the Safeguarding Therapeutics Act, FDA aims to follow certain
conventions when referencing the terms “device” and “counterfeit device.” For consistency with
prior documents, we will generally continue to reference section 201(h) of the FD&C Act for the
definition of “device.” For example, a future FDA guidance might read:
Section 3060(a) of the 21st Century Cures Act amended the FD&C Act to add section
520(o), which excludes certain software functions from the definition of device in section
201(h) of the FD&C Act.
In certain instances, FDA and others may utilize the more precise reference to section 201(h)(1)
of the FD&C Act. Instances in which FDA may opt to reference paragraph (1) of subsection (h)
specifically include quoting the definition of “device” in part or in its entirety, referring to
statements contained in subparagraphs (A) through (C), or maintaining consistency with other
definitions in the same document.9
For example, when referring to the structure/function prong of the “device” definition, FDA may
cite to subparagraph (C) of section 201(h)(1) of the FD&C Act for precision:
FDA considers needle penetration beyond the stratum corneum as a result of the design
or technology of a microneedling product as evidence that it may be “intended to affect
the structure or any function of the body” under section 201(h)(1)(C) of FD&C Act.
As another example, the preamble to a proposed rule could refer to the definitions of a “drug”
and a “device” at sections 201(g)(1) and 201(h)(1) of the FD&C Act, respectively, for
consistency:
Among the provisions that provide authority for this proposed rule are sections 201 and
503(g) of the FD&C Act, and section 351(i) of the Public Health Service Act (PHS Act).
Section 201 of the FD&C Act defines “drug” (subsection (g)(1)) and “device”
(subsection (h)(1)); and section 503(g) of the FD&C Act provides that combination
products are those “that constitute a combination of a drug, device, or biological
product.” Section 351(i) of the PHS Act defines “biological product” (42 U.S.C. 262(i)),
and section 351(j) of the PHS Act provides that the requirements of the FD&C Act apply
to biological products (42 U.S.C. 262(j)).
Most importantly, whether FDA cites to section 201(h) or to 201(h)(1) of the FD&C Act, FDA’s
intent should not be understood to be any different. In either case, we are intending to refer
readers to the definition of “device” contained in paragraph (1) of section 201(h) of the FD&C
Act, or to otherwise apply policies to or reference devices that meet the definition in paragraph
(1), but not to counterfeit devices defined in paragraph (2). Deviations from the conventions
described in this guidance document should not alone be considered to have legal significance.
9 The definition of drug is codified at section 201(g)(1) of the FD&C Act, though FDA, Congress, and others
alternate between referencing subsection (g) and (g)(1).

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In the event that FDA intends to reference the definition of a “counterfeit device” in a document,
FDA aims to do so expressly with a reference to section 201(h)(2) of the FD&C Act.
References to the Term “Device” in Documents FDA
Receives
FDA expects to receive documents, such as premarket submissions, reports, and other
communications and inquiries, from industry and other stakeholders that include references to
the term “device” and to the corresponding provisions of the FD&C Act. As appropriate, FDA
will attempt to employ the same conventions described in this guidance document when
interpreting documents that we receive from such stakeholders. Thus, we encourage stakeholders
to align with the recommendations described herein to the extent practicable.