Contains Nonbinding Recommendations
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recognizes that it will take time for device
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manufacturers,
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device distributors, healthcare
facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and
operations implemented during the COVID-19 public health emergency (PHE) to “normal
operations.”
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To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing
this guidance to describe FDA’s general recommendations for a phased transition process with
respect to devices that fall within certain enforcement policies issued during the COVID-19
PHE, including recommendations regarding submitting a marketing submission, as applicable,
and taking other actions with respect to these devices.
FDA is concurrently issuing a companion transition guidance to describe FDA’s
recommendations for devices issued emergency use authorizations (EUAs) related to COVID-
19.
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The companion transition guidance does not include phases as described in this transition
plan for devices that fall within enforcement policies and instead relies on the advance notice(s)
of termination process required under section 564 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). FDA believes that these transition guidances will help prepare manufacturers and
other stakeholders for the transition to normal operations and foster compliance with applicable
requirements under the FD&C Act and its implementing regulations.
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
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Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act provides that the term “device” 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)” of the
Federal Food, Drug, and Cosmetic Act.
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Throughout this guidance, when describing policies for devices that fall within enforcement policies issued during
the COVID-19 public health emergency declared under section 319 of the Public Health Service Act, FDA uses the
term “manufacturer” to refer to any person who designs, manufactures, fabricates, assembles, or processes a finished
device. See 21 CFR 820.3(o). Other entities, including those that introduce such devices into commercial
distribution, such as initial importers and certain distributors, should ensure they understand, and where applicable,
they should follow, the recommendations that pertain to such devices.
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Throughout this guidance, FDA refers to “normal operations” as a shorthand for the circumstances when the
declaration of the PHE related to COVID-19 under section 319 of the Public Health Service Act has expired and/or
the relevant device emergency use declarations related to COVID-19 under section 564 of the Federal Food, Drug,
and Cosmetic Act are terminated.
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The guidance “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID-19),” available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-related-
coronavirus-disease, will be referred to as the “companion transition guidance” in the remainder of this guidance.