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 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
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, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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.
1 Contains Nonbinding Recommendations
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.
2 Contains Nonbinding Recommendations
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 FDAs 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 FDAs intent to exercise enforcement 
discretion or otherwise extend certain policies to counterfeit devices.8
6 42 U.S.C. 247d6d(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, FDAs enforcement policies 
applicable to devices that describe FDAs intent not to enforce certain requirements of the FD&C Act do not apply 
to counterfeit devices.
3 Contains Nonbinding Recommendations
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, FDAs 
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).
4 Contains Nonbinding Recommendations
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.
5