Contains Nonbinding Recommendations 
 
 
Transition Plan for Medical Devices 
That Fall Within Enforcement Policies 
Issued During the Coronavirus Disease 
2019 (COVID-19) Public Health 
Emergency
 
Guidance for Industry, Other 
Stakeholders, and Food and Drug 
Administration Staff 
 
Document issued on March 27, 2023. 
 
The draft of this document was issued on December 23, 2021. 
 
For questions about this document, contact the Regulation, Policy, and Guidance Staff at 
RPG@fda.hhs.gov.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
  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-1118. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
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 
GUI00021011 and complete title of the guidance in the request. 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
I.  Introduction ............................................................................................................................. 1 
 
II.  Background ............................................................................................................................. 3 
III.  Scope ....................................................................................................................................... 5 
IV.  Guiding Principles .................................................................................................................. 6 
V.  Phased Transition Plan for Devices That Fall Within COVID-19 Enforcement Policies 
Described in Guidances in List 1 .................................................................................................... 7 
A.  Devices not distributed after Phase 2 ................................................................................ 11 
B.  Phase 1 .............................................................................................................................. 13 
C.  Phase 2 .............................................................................................................................. 13 
(1)  Notifications of Intent for Certain Reusable Life-Supporting or Life-Sustaining 
Devices .................................................................................................................................. 14 
D.  Phase 3 .............................................................................................................................. 15 
(1)  Enforcement policy for devices with a marketing submission under review by FDA 16 
(2) Recommendations for Transition Implementation Plan .............................................. 18 
E.  Discontinuing distribution of a device .............................................................................. 20 
F.  Quality System considerations .......................................................................................... 21 
VI.  Examples ............................................................................................................................... 21 
Example 1 ................................................................................................................................. 21 
Example 2 ................................................................................................................................. 23 
Example 3 ................................................................................................................................. 24 
Example 4 ................................................................................................................................. 25 
 
  Contains Nonbinding Recommendations 
 
 
Transition Plan for Medical Devices 
That Fall Within Enforcement Policies 
Issued During the Coronavirus Disease 
2019 (COVID-19) Public Health 
Emergency
 
Guidance for Industry, Other 
Stakeholders, 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 
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging 
infectious diseases, including Coronavirus Disease 2019 (COVID-19). FDA is committed to 
providing timely guidance to support response efforts to the COVID-19 pandemic. FDA 
1  Contains Nonbinding Recommendations 
 
 
recognizes that it will take time for device1 manufacturers,2 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.3 To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing 
this guidance to describe FDAs 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 FDAs 
recommendations for devices issued emergency use authorizations (EUAs) related to COVID-
19.4 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, 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 
 
 
1 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. 
2 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.  
3 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. 
4 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. 
2  Contains Nonbinding Recommendations 
 
 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
II.  Background 
In 2019, an outbreak of respiratory disease caused by a novel coronavirus began. The virus has 
been named SARS-CoV-2, and the disease it causes has been named Coronavirus Disease 
2019 (COVID-19). On January 31, 2020, the Secretary of Health and Human Services (HHS) 
issued a declaration of a PHE related to COVID-19 in accordance with section 319 of the Public 
Health Service (PHS Act) (hereinafter referred to as section 319 PHE declaration) and 
mobilized the Operating Divisions of HHS.5 In addition, on March 13, 2020, the President 
declared a national emergency in response to COVID-19.6 On February 9, 2023, the HHS 
Secretary renewed the section 319 PHE declaration related to COVID-19, effective February 11, 
2023. The section 319 PHE declaration related to COVID-19 is anticipated to expire at the end 
of the day on May 11, 2023.7 
 
In response to the COVID-19 pandemic, the device supply chain has been stressed because the 
demand for certain devices has exceeded available supply. FDA recognized early in the COVID-
19 pandemic the importance of maintaining the availability of certain devices. FDAs policies 
have helped facilitate the availability of devices intended to diagnose, treat, and prevent COVID-
19 and associated conditions  including mitigating exposure to the SARS-CoV-2 virus  and to 
help address manufacturing limitations or supply chain issues due to disruptions caused by the 
COVID-19 pandemic.  
 
FDA issued various guidance documents that describe enforcement policies for certain 
devices that are intended to support the emergency response to the COVID-19 pandemic.8 
These policies have helped to facilitate the availability of devices such as in vitro diagnostics, 
personal protective equipment intended for medical purposes, and ventilators. Additionally, 
FDA issued guidance to help expand the availability and remote monitoring capabilities of 
 
 
5 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued 
on January 31, 2020, and subsequently renewed), available at 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. 
6 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) 
Outbreak (March 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-
declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, 
there was a Presidential Declaration continuing the national emergency concerning the COVID-19 pandemic beyond 
March 1, 2021. See Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-
19) Pandemic (86 FR 11599), available at https://www.federalregister.gov/documents/2021/02/26/2021-
04173/continuation-ofthe-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic. 
7 See the HHS Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, (February 9, 2023), 
available at https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-
roadmap.html. 
8 For links to the COVID-19-related FDA guidances, see the webpage COVID-19-Related Guidance Documents 
for Industry, FDA Staff, and Other Stakeholders, available at https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-
stakeholders. 
3  Contains Nonbinding Recommendations 
 
 
certain devices, including infusion pumps and non-invasive remote patient monitoring 
devices, to reduce the risk of exposure for patients, healthcare providers, and other healthcare 
professionals to individuals diagnosed with COVID-19.  
 
Generally, the guidances that set forth COVID-19-related enforcement policies for certain 
devices initially stated that they were intended to remain in effect only for the duration of the 
section 319 PHE declaration. As FDA announced in the Federal Register on March 13, 2023, 
many of these guidance documents  the guidances in List 1 (see below)  have been revised 
to state that they are intended to continue in effect for 180 days after the section 319 PHE 
declaration expires unless a different intended duration is set forth in the finalized version of 
this guidance.9,10 A different intended duration is not being set forth in this guidance  as 
described in Section V., the implementation date is the date the section 319 PHE declaration 
expires and the guidances are intended to continue in effect for 180 days after that date. FDA 
recommends reviewing the cover page for the relevant List 1 guidance to help determine the 
transition period for your device.  
 
Given the magnitude of the response to the COVID-19 pandemic, FDA recognizes that a 
phased approach may help to ensure an orderly and transparent transition from the policies 
and recommendations in the List 1 guidances to normal operations. Further, FDA is taking 
into account that the manufacture, distribution, and use of devices in the context of the 
COVID-19 pandemic raises unique considerations. These unique considerations include, for 
example, the manufacturing of devices by non-traditional manufacturers to address supply 
issues and the distribution and use of capital or reusable equipment (e.g., ventilators, 
extracorporeal membrane oxygenation systems) that fall within enforcement policies. 
 
FDA developed this guidance to describe a phased approach, as set forth in Section V., among 
other things, to help avoid disruption in device supply and help facilitate compliance with 
applicable legal requirements after the enforcement policies are no longer in effect. This 
phased approach will allow FDA to better understand the landscape of devices that fall within 
the relevant enforcement policies, provide support to manufacturers, and assist the Agency in 
resource planning for marketing submission review. 
 
 
 
 
 
 
9 See Guidance Documents Related to Coronavirus Disease 2019 (COVID-19) (88 FR 15417), available at 
https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-
disease-2019-covid-19. As discussed in that notice, FDA intends to further revise 4 of these COVID-19-related 
device guidances during the 180-day transition period after the section 319 PHE declaration expires (see Section 
IV., Table 3 of that notice). Also, as noted in that document, 2 COVID-19-related device guidances will no longer 
be in effect when the section 319 PHE declaration expires (see Section II., Table 1 of that notice). 
10 Although the duration of these guidances has been extended, we note that FDA could withdraw any of these 
guidances before that 180-day transition period ends if, for example, our approach for a particular guidance is no 
longer needed. FDA would do so consistent with our good guidance practices regulation (21 CFR 10.115). 
4  Contains Nonbinding Recommendations 
 
 
III.  Scope 
This guidance applies to devices that fall within the enforcement policies described in the 
guidances identified in List 1 below.11 
 
List 1 
  Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 
Public Health Emergency12 
  Enforcement Policy for Imaging Systems During the COVID-19 Public Health 
Emergency13 
  Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to 
Support Patient Monitoring During the COVID-19 Public Health Emergency14 
  Enforcement Policy for Telethermographic Systems During the COVID-19 Public 
Health Emergency15 
  Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders 
During the COVID-19 Public Health Emergency16 
  Enforcement Policy for Extracorporeal Membrane Oxygenation and 
Cardiopulmonary Bypass Devices During the COVID-19 Public Health Emergency17 
 
 
11 This guidance does not apply to devices that fall within the enforcement policies described in the following 
guidances: Policy for Coronavirus Disease-2019 Tests (Revised), available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-revised; Policy for Evaluating 
Impact of Viral Mutations on COVID-19 Tests (Revised), available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/policy-evaluating-impact-viral-mutations-covid-19-tests-revised; 
Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 
Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/enforcement-policy-quality-standards-mammography-quality-standards-act-during-covid-19-public-
health; Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring 
During the COVID-19 Public Health Emergency (Revised), available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-
support-patient-monitoring-during; Enforcement Policy for Clinical Electronic Thermometers During the COVID-
19 Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/enforcement-policy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-public; 
and Enforcement Policy for Face Masks and Barrier Face Coverings During the COVID-19 Public Health 
Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-
policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public.  
12Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
remote-digital-pathology-devices-during-coronavirus-disease-2019-covid-19-public. 
13Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
imaging-systems-during-coronavirus-disease-2019-covid-19-public-health-emergency. 
14Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-
invasive-fetal-and-maternal-monitoring-devices-used-support-patient. 
15Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health. 
16Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
digital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease. 
17Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
extracorporeal-membrane-oxygenation-and-cardiopulmonary-bypass-devices-during. 
5  Contains Nonbinding Recommendations 
 
 
  Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices 
During the COVID-19 Public Health Emergency18 
  Enforcement Policy for Infusion Pumps and Accessories During the COVID-19 
Public Health Emergency19 
  Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the 
COVID-19 Public Health Emergency 20 
  Enforcement Policy for Gowns, Other Apparel, and Gloves During the COVID-19 
Public Health Emergency21 
  Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the 
COVID-19 Public Health Emergency22 
  Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices 
During the COVID-19 Public Health Emergency23 
  Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV 
Tests During the COVID-19 Public Health Emergency24 
  Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement 
Policy During the COVID-19 Public Health Emergency (Revised)25 
  Enforcement Policy for Viral Transport Media During the COVID-19 Public Health 
Emergency (Revised)26 
 
IV.  Guiding Principles 
In developing this guidance, and its companion transition guidance regarding devices issued 
EUAs related to COVID-19, several guiding principles were followed. Some derive from 
existing policies and are widely known, and others are key to understanding the approach set 
 
 
18Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
remote-ophthalmic-assessment-and-monitoring-devices-during-coronavirus-disease. 
19Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
infusion-pumps-and-accessories-during-coronavirus-disease-2019-covid-19-public. 
20Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
face-shields-surgical-masks-and-respirators-during-coronavirus-disease-covid-19. Bifucaration of the Enforcement 
Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the COVID-
19 Public Health Emergency (Revised) guidance was announced in the Federal Register notice on March 13, 2023 
(88 FR 15417). The guidance relating to face shields, surgical masks, and respirators is in List 1, and the guidance 
related to face masks and barrier face coverings, as noted in footnote 11, is outside the scope of this guidance. 
21Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health. 
22Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
sterilizers-disinfectant-devices-and-air-purifiers-during-coronavirus-disease. 
23Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus. 
24Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
modifications-fda-cleared-molecular-influenza-and-rsv-tests-during-coronavirus. 
25Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/coagulation-systems-
measurement-viscoelastic-properties-enforcement-policy-during-coronavirus. 
26Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health.  
6  Contains Nonbinding Recommendations 
 
 
forth in this guidance. Thus, anyone using this guidance should bear in mind the following 
guiding principles: 
 
  This guidance is intended to help facilitate continued patient, consumer, and healthcare 
provider access to devices needed in the prevention, treatment, and diagnosis of COVID-
19. 
  FDA believes the policies and recommendations in this guidance will help to ensure an 
orderly and transparent transition for devices that fall within the scope of this guidance. 
FDAs policies and recommendations in this guidance are consistent with the Agencys 
statutory mission to both protect and promote the public health.27 
  FDAs policies and recommendations follow, among other things, a risk-based approach 
with consideration of differences in the intended use and regulatory history of devices, 
including whether the device is life-supporting or life-sustaining,28 capital or reusable29 
equipment, a single-use device,30 and whether another version of the device is FDA-
cleared or -approved. 
  As always, FDA will make case-by-case decisions regarding the enforcement of legal 
requirements in response to particular circumstances and questions that arise regarding a 
specific device or device type. This may include requesting a firm initiate a recall (see 21 
CFR 7.45),31 or taking other actions, including an enforcement action. Moreover, FDA 
may revise the enforcement policies and recommendations in the guidance, as 
appropriate. 
 
V.  Phased Transition Plan for Devices That Fall Within 
COVID-19 Enforcement Policies Described in 
Guidances in List 1 
As previously stated, FDA recognizes that it will take time for device manufacturers, device 
distributors, healthcare facilities, healthcare providers, patients, consumers, and the Agency to 
adjust from policies adopted and operations implemented during the COVID-19 PHE to normal 
 
 
27 See section 1003(b) of the FD&C Act. 
28 Life-supporting or life-sustaining devices are defined in 21 CFR 860.3. A list of life-supporting or life-sustaining 
devices can be found by searching FDAs product classification database: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. 
29 A reusable device is intended for repeated use either on the same or different patients, with appropriate cleaning 
and other reprocessing between uses. For additional information see the guidance Reprocessing Medical Devices in 
Health Care Settings: Validation Methods and Labeling, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-
and-labeling. 
30 A single-use device is a device that is intended for one use or on a single patient during a single procedure. For 
additional information see the guidance Reprocessing Medical Devices in Health Care Settings: Validation 
Methods and Labeling. 
31 21 CFR 7.45(a) states that FDA may request a firm to initiate a recall when the following determinations have 
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer 
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect 
the public health and welfare. 
7  Contains Nonbinding Recommendations 
 
 
operations. FDA seeks to encourage and facilitate an appropriate transition period to help, among 
other things, avoid exacerbating product shortages and supply chain disruptions. This transition 
plan takes into account that the guidances in List 1 will no longer be in effect after the 180-day 
transition period discussed in this guidance ends. The discussion below contains 
recommendations regarding the preparation and submission of marketing submissions (including 
the timing of such submissions),32 manufacturers actions if they do not wish to continue 
distributing their product after the end of Phase 2, and the distribution of devices that fall within 
the scope of this guidance.  
 
For purposes of this guidance, devices are considered to be already distributed if they are 
finished devices33 that are labeled and are in distribution34 in the U.S. supply chain or are in the 
possession of the end user. For purposes of this guidance, FDA would generally consider devices 
to be in distribution to mean those finished, labeled devices that are no longer in the 
manufacturers possession that are in transit to or held in a third partys device inventory not on 
behalf of the manufacturer, in a federal, state, or other government stockpile, or at a location 
where devices are then offered for direct sale to the end user.   
 
Given the duration of the COVID-19 pandemic and the need to safeguard the public health in a 
post-pandemic environment, FDA is implementing a 180-day transition period that will begin on 
the implementation date (see discussion below regarding this date). The guidances in List 1 
will no longer be in effect after the 180-day transition period ends. FDA believes a phased 
transition over the 180 days following the implementation date as set forth in this guidance will 
help foster compliance with applicable legal requirements. This approach consists of three 
phases as described later in this section and outlined in Table 2. 
 
The implementation date is the date the COVID-19 section 319 PHE declaration expires or 45 
days after the finalization of this guidance, whichever comes later. Because the COVID-19 
section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of 
this guidance, or May 11, 2023, the implementation date is that date. The guidance documents 
identified in List 1 will no longer be in effect after the 180-day transition period ends, or after 
November 7, 2023.  
 
 
 
 
 
 
 
 
 
32 For purposes of this guidance, marketing submission means a premarket approval application (PMA), PMA 
supplement, premarket notification (510(k)) submission, humanitarian device exemption (HDE) application, or De 
Novo classification request (De Novo). For devices that are class I or II and exempt from premarket notification 
(e.g., shoe covers, face shields), no 510(k) submission is required unless the limitations of exemption are exceeded 
(see, e.g., 21 CFR 878.9). 
33 See 21 CFR 820.3(l). 
34 See 21 CFR 807.3(b) (defining commercial distribution). 
8  Contains Nonbinding Recommendations 
 
 
 
A timeline for this process is provided in Figure 1. 
 
 
Figure 1. Transition Timeline. Implementation date occurring on the date the COVID-19 
section 319 PHE declaration expires. 
 
In the bullets below, FDA describes our transition period expectations and recommendations for 
all manufacturers that distributed devices as described in an enforcement policy in a guidance in 
List 1, both for those who do and do not pursue marketing authorization for their devices. FDA 
believes these expectations and recommendations will help facilitate a smooth and consistent 
transition to normal operations.  
 
A summary of the three phases are as follows: 
 
  Phase 1: Begins on the implementation date. If not already doing so, manufacturers 
should follow 21 CFR Part 803 (i.e., adverse event reporting requirements) in order to 
prepare for Phase 3.  
 
  Phase 2: Begins 90 days after the implementation date. Before the start of Phase 2 and in 
order to prepare for Phase 3, if not already doing so, manufacturers should: (1) follow 21 
CFR Part 806 (i.e., reports of corrections and removals requirements), and (2) if planning 
to continue to distribute their devices after Phase 2, should also follow 21 CFR Part 807 
Subparts B-D (i.e., registration and listing requirements).  
 
  Phase 3: Begins 180 days after the implementation date. After the 180-day transition 
period ends, the guidances in List 1 will no longer be in effect. At this time, FDA does 
not intend to object to continued distribution of devices within the scope of this guidance 
9  Contains Nonbinding Recommendations 
 
 
where a required marketing submission has been submitted and accepted35 by FDA 
before the start of Phase 3 and FDA has not taken a final action36 on the marketing 
submission. In addition, for these same devices, while the device is under FDA review, 
FDA does not intend to object to the devices not complying with certain Unique Device 
Identification (UDI) requirements (see 21 CFR Part 801 Subpart B) and other applicable 
labeling requirements (see 21 CFR Part 801) (see Section V.D.(1) of this guidance). This 
enforcement policy does not apply to other legal requirements (such as registration and 
listing, Quality System (QS), and reports of corrections and removals requirements under 
21 CFR Parts 807, 820, and 806, respectively). 
 
The three phases of the transition plan, including additional considerations and recommendations 
related to each phase, are described in more detail below.  
 
FDA recommends manufacturers submit a Transition Implementation Plan with their 
marketing submission that addresses the manufacturers plans for dealing with devices already 
distributed in the case of a positive decision as well as in the case of a negative decision on the 
marketing submission (see Section V.D.(2) of this guidance). The marketing submission should 
be administratively complete in that it includes all of the information necessary for FDA to 
conduct a substantive review.37 FDA understands there may be extenuating circumstances that 
make doing so difficult (e.g., ongoing clinical trial or longer term non-clinical studies). 
Manufacturers in such circumstances should engage with the Agency early in the transition 
period.38 
 
FDA understands that there may be scenarios that are not specifically addressed in this guidance, 
but generally believes that the policies and recommendations described in Table 2, regardless of 
the specific scenario for a manufacturer, will help avoid disruptions in critical devices and allow 
 
 
35 For more information regarding FDAs acceptance policies for marketing submissions, see the guidances Refuse 
to Accept Policy for 510(k)s, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/refuse-accept-policy-510ks, Acceptance and Filing Reviews for Premarket Approval Applications 
(PMAs), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-and-
filing-reviews-premarket-approval-applications-pmas, and Acceptance Review for De Novo Classification 
Requests, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-
review-de-novo-classification-requests. 
36 For purposes of this guidance, FDA uses the term final action to mean a Medical Device User Fee Amendments 
(MDUFA) decision, which can include positive decisions, negative decisions, and notices of withdrawals, consistent 
with the: 510(k) Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-
and-goals; De Novo Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals; 
PMA Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/fda-and-industry-actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals. 
37 See footnote 35.  
38 FDA recommends that manufacturers engage with the Agency through the Q-Submission Program, including 
requesting Pre-Submissions, to discuss extenuating circumstances. For details on the Q-Submission Program, refer 
to the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-
feedback-and-meetings-medical-device-submissions-q-submission-program. 
10  Contains Nonbinding Recommendations 
 
 
FDA to best manage its resources for review of marketing submissions. To address any unique 
considerations or other issues not otherwise discussed in this guidance, manufacturers may wish 
to initiate discussions with the Agency through the Q-Submission Program, including requesting 
feedback in Pre-Submissions. If the manufacturers intent is to continue to distribute its device 
after Phase 2, the manufacturer should promptly start preparing, and FDA intends to help 
facilitate acceptance of, a marketing submission before Phase 3 begins. For details on the Q-
Submission Program, refer to the guidance Requests for Feedback and Meetings for Medical 
Device Submissions: The Q-Submission Program.39 
 
A. Devices not distributed after Phase 2  
When a manufacturer that has been distributing its device as described in an enforcement policy 
in a guidance in List 1 does not intend to continue to distribute its device after Phase 2, at this 
time, FDA does not intend to object to the disposition and use40 of already distributed devices 
(i.e., FDA does not intend to request market removal41) as follows: 
 
1)  Single-use, non-life-supporting/non-life-sustaining devices (e.g., face masks) that were 
distributed before the end of Phase 2 are used by the end user prior to the product 
expiration date, as applicable. 
2)  Reusable, non-life-supporting/non-life-sustaining devices (e.g., infusion pumps) that 
were distributed before the end of Phase 2 are used by their end user and either:  
a.  Are restored42 by the manufacturer to an FDA-cleared or -approved version of the 
device,43 or  
b.  Have44 a physical and/or electronic copy of updated labeling that accurately 
describes the product features and regulatory status (e.g., that the product lacks 
FDA clearance, approval, or authorization). 
3)  Reusable life-supporting/life-sustaining devices (e.g., ventilators, extracorporeal 
membrane oxygenation systems) that were distributed before the end of Phase 2 are 
restored45 by the manufacturer to an FDA-cleared or -approved version of the device46 so 
that they may be used by their end user. If not restored, a physical and/or electronic copy 
of updated labeling that accurately describes the product features and regulatory status 
 
 
39 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program. 
40 FDA recognizes that not all uses would necessarily be violative. To the extent such use is violative, FDA 
generally does not intend to object as described herein.  
41 FDA uses the term removal consistent with the definition in 21 CFR 806.2(j). 
42 In situations where manufacturers do not believe restoration is possible or in the best interest of public health, 
FDA recommends additional engagement with the Agency on the appropriate disposition of a product if it is not 
otherwise discussed in this guidance. 
43 For example, an FDA-cleared or -approved version may include an earlier software version, component 
replacement, or different labeling that removes information related to the use of the device as described in an 
enforcement policy. 
44 The manufacturer should provide labeling to the original purchaser, and collaborate with the original purchaser to 
ensure that labeling is distributed to relevant stakeholders, including device distributors, healthcare facilities, 
healthcare providers, patients, consumers, etc. 
45 See footnote 42. 
46 See footnote 43. 
11  Contains Nonbinding Recommendations 
 
 
(e.g., that the product lacks FDA clearance, approval, or authorization) should be 
provided,47 and such devices are not to be used.48,49 To help ensure accessibility to 
updated labeling, FDA recommends that stakeholders be provided an opportunity to 
request a physical copy of updated labeling, and after such request, be provided the 
requested labeling without additional cost. 
 
Manufacturers that do not intend to distribute their devices after Phase 2 should also refer to 
relevant information included in other sections of this guidance (though note that 
recommendations in Section V.D.(1) are intended only for manufacturers that intend to distribute 
their device after the end of Phase 2). In addition, manufacturers should be aware of any 
applicable legal requirements for their device, such as adverse event reporting under 21 CFR Part 
803, and are expected to comply with such requirements for the duration in which they are 
applicable, which may extend beyond the cessation of distribution. 
Manufacturers may also voluntarily withdraw their devices from the market. For manufacturers 
that do not intend to continue distributing their devices and that intend to voluntarily withdraw 
their devices from the market, FDA recommends completing withdrawal of the devices from the 
market prior to the withdrawal of the guidances in List 1; otherwise, if withdrawal of the devices 
from the market is not completed prior to the withdrawal of the guidances in List 1, FDA 
recommends restoring and/or updating labeling for reusable non-life-supporting/non-life-
sustaining devices and for reusable life-supporting/life-sustaining devices as outlined in the 
policy above prior to the withdrawal of the guidances in List 1. Manufacturers should be aware 
of any applicable legal requirements for their device, such as adverse event reporting under 21 
CFR Part 803, and continue to comply with such requirements for the duration in which they are 
applicable, which may extend beyond the cessation of distribution or withdrawal. Generally, it is 
anticipated that, over time, legal requirements will no longer apply when the manufacturers 
device withdrawal activities are completed. 
 
FDA encourages manufacturers that do not intend to continue to distribute their devices after 
Phase 2 to communicate with device distributors, healthcare facilities, healthcare providers, 
patients, and consumers, as appropriate, regarding their product disposition to assist all 
stakeholders with transition planning. In addition, thinking through elements of the Transition 
Implementation Plan outlined in Section V.D.(2) of this guidance may help manufacturers and 
stakeholders with this process. 
 
 
 
 
 
47 See footnote 44. 
48 FDA recognizes that not all use would necessarily be violative. 
49 Should healthcare facilities wish to retain a device that lacks FDA clearance, approval, or authorization for use in 
the future, the future use of the device would be subject to the regulatory requirements of any future authorization, 
including marketing authorization or EUA, as applicable. For governmental stockpilers that wish to retain a device 
that lacks requisite FDA clearance, approval, or authorization for use in the future, FDA recommends engaging with 
the Agency to discuss the public health need for future deployment and/or use of the device in specific 
circumstances (e.g., regional natural disaster, localized disease outbreaks). 
12  Contains Nonbinding Recommendations 
 
 
B. Phase 1 
Phase 1 starts on the implementation date, as described above. In order to prepare for Phase 3, if 
not already doing so, manufacturers should follow adverse event reporting requirements50 under 
21 CFR Part 803. Manufacturers should submit any adverse event reports that were stored (e.g., 
because of pandemic-related high employee absenteeism) and should refer to applicable FDA 
guidance regarding adverse event reporting during a pandemic.  
 
During (and preferably before the start of) this phase, manufacturers that intend to continue 
distribution of their devices after Phase 2 should begin preparation of any required marketing 
submission to help avoid disruptions in critical devices and allow FDA to best manage its 
resources for review of marketing submissions. While preparing a marketing submission, 
manufacturers can use the FDA Guidance Search Tool51 to identify relevant guidance documents 
that may be helpful in preparing the submission. 
  
FDA is taking into account that the use of devices during the COVID-19 pandemic may allow 
manufacturers to utilize a variety of data sources in their marketing submission. As such, FDA 
anticipates many manufacturers may wish to reference data from related marketing 
authorizations and submissions, and use real-world data obtained as a result of device use during 
the COVID-19 pandemic.52 FDA recommends that marketing submissions include in the cover 
letter a statement that the device was distributed as described in an enforcement policy, as well 
as submission number(s) for related premarket submissions. This information will help FDA 
track devices that are transitioning to the required marketing authorization,53 facilitate review of 
the submission, and help ensure that the transitioning devices can be appropriately considered in 
light of the policy described in Section V.D.(1) of this guidance.  
 
C. Phase 2 
Phase 2 begins 90 days after the implementation date. Before the start of Phase 2 and in order to 
prepare for Phase 3, if not already doing so, manufacturers should follow correction and removal 
requirements under 21 CFR Part 806. Before the start of Phase 2, manufacturers that intend to 
continue to distribute their devices after Phase 2 should also register their establishments and 
list54 their device(s) or update existing registration and listing (R&L) if they have not already 
done so. For manufacturers that register and list by the start of Phase 2, FDA recommends that 
manufacturers utilize the term enforcement (as a shorthand for enforcement policy) in the 
premarket submission field if a submission number is not yet available. If the device 
 
 
50 For more information on adverse event reporting requirements under 21 CFR Part 803, see the guidance Medical 
Device Reporting for Manufacturers, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/medical-device-reporting-manufacturers.  
51 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/. 
52 Data derived from real-world sources may be submitted in support of a marketing submission. See the guidance 
titled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-
regulatory-decision-making-medical-devices. 
53 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act. 
54 21 CFR Part 807, Subparts B-D. 
13  Contains Nonbinding Recommendations 
 
 
subsequently receives marketing authorization, FDA expects manufacturers to comply with all 
applicable registration and listing requirements, which may require updating the listing 
information.  
 
As discussed above, manufacturers that intend to continue to distribute their devices after Phase 
2 should continue preparation of any required marketing submission55 as FDA expects such 
manufacturers to submit a marketing submission to FDA and have it accepted before the start of 
Phase 3 to help avoid disruptions in critical devices and allow FDA to best manage its resources 
for review of marketing submissions.  
 
In addition, FDA recommends that manufacturers of certain life-supporting or life-sustaining 
devices within the scope of this guidance  regardless of whether they intend to continue 
distribution of their devices after Phase 2  submit a Notification of Intent to FDA as described 
in Section V.C.(1) of this guidance. 
 
(1)  Notifications of Intent for Certain Reusable Life-
Supporting or Life-Sustaining Devices 
Given the public health significance of certain reusable life-supporting or life-sustaining devices, 
FDA requests that manufacturers of such devices submit to FDA information about whether or 
not they intend to submit a marketing submission to FDA and continue distributing their product 
after Phase 2. This information will assist the Agency in resource planning for marketing 
submission review and providing support to manufacturers. This request applies to devices that 
fall within the scope of this guidance and that have a product code listed in Table 1: 
 
Table 1 
Product Code  Device Type  Classification Regulation 
BSZ  Gas-machine, anesthesia  21 CFR 868.5160 
CAW  Generator, oxygen, portable  21 CFR 868.5440 
Humidifier, respiratory gas, (direct 
BTT  21 CFR 868.5450 
patient interface)  
High flow/high velocity humidified 
QAV  21 CFR 868.5454 
oxygen delivery device 
Ventilator, continuous, facility 
CBK 
use 
Ventilator, continuous, minimal 
MNT 
ventilatory support, facility use 
21 CFR 868.5895 
NOU  Continuous, ventilator, home use 
Ventilator, continuous, non-life-
MNS 
supporting 
 
 
55 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act. 
 
14  Contains Nonbinding Recommendations 
 
 
Product Code  Device Type  Classification Regulation 
ONZ  Mechanical ventilator 
Ventilator, emergency, powered 
BTL  21 CFR 868.5925 
(resuscitator) 
 
Manufacturers of the devices identified in Table 1 should submit the following information to the 
CDRH Document Control Center56 before the start of Phase 2:57 
 
  General information about the manufacturer, including contact information, name and 
place of business, and email address; 
  Title of the relevant enforcement policy guidance; 
  Submission number(s) for related premarket submissions; 
  A list of all model numbers or other device identifying information; 
  Whether the manufacturer plans to submit a marketing submission; and 
  If not planning to submit a marketing submission, the manufacturer should discuss, as 
applicable, its plans to discontinue distribution of the device, to restore the device to an 
FDA-cleared or -approved version, to provide a physical copy and/or electronic copy of 
updated labeling, and any other efforts to address or mitigate potential risks of devices 
that remain distributed after Phase 2. 
 
If another version of the device is FDA-cleared or -approved and a modified version is/was 
distributed as described in a policy in a guidance in List 1, the manufacturer should submit this 
information in a premarket notification (i.e., 510(k)) or PMA amendment for the cleared or 
approved device.58 FDA recommends that manufacturers notate the following on the cover letter 
of the submission: Attention: Notification of Intent. To the extent the Notification of Intent 
contains trade secret information or confidential commercial or financial information, FDA will 
handle that information in accordance with applicable laws, including 21 CFR 20.61. 
 
D. Phase 3 
Phase 3 begins 180 days after the implementation date. After the 180-day transition period ends, 
the guidances in List 1 will no longer be in effect. Before the start of Phase 3, any required 
 
 
56 The mailing address for the CDRH Document Control Center can be found in 21 CFR 807.90(a)(1) and 
814.104(d)(1). FDA encourages manufacturers to submit Notifications of Intent as eCopies. Information about the 
eCopy program can be found in the guidance eCopy Program for Medical Device Submissions, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. 
57 Submitting this information as soon as possible after issuance of this guidance is encouraged because it will assist 
the Agency in resource planning, help to avoid any supply disruptions, and otherwise help to ensure a smooth 
transition for these devices after the guidances in List 1 are no longer in effect. 
58 FDA recommends that the information be submitted as an amendment to the 510(k) or PMA file to facilitate 
efficient tracking of the Notification of Intent submissions. 
15  Contains Nonbinding Recommendations 
 
 
marketing submission59 is expected to be submitted to and accepted by FDA if the manufacturer 
intends to continue distribution of the device after Phase 2. Where possible, FDA strongly 
encourages manufacturers to work to complete such submissions well in advance of the start of 
Phase 3 to avoid potential delays created by a large influx of new submissions and to best serve 
the public health. 
 
(1)  Enforcement policy for devices with a marketing submission 
under review by FDA  
As previously stated, FDA recognizes that it may take time for device manufacturers, including 
non-traditional device manufacturers, to adapt and adjust from their operations during the 
COVID-19 PHE to normal operations. As such, at this time, FDA does not intend to object to the 
continued distribution of devices within the scope of this guidance after the guidances in List 1 
are no longer in effect where:  
 
  The manufacturer has submitted a marketing submission60 to FDA and it is accepted61 by 
FDA before the start of Phase 3; and 
  FDA has not taken a final action62 on the marketing submission. 
 
For these same devices, while the device is under FDA review, FDA does not intend to object to 
the devices not complying with certain UDI requirements (see 21 CFR Part 801 Subpart B) or 
other applicable labeling requirements (see 21 CFR Part 801) where the device continues to be 
labeled as described in the relevant List 1 guidance.63,64 As always, FDA will make case-by-case 
decisions regarding the enforcement of legal requirements in response to particular 
circumstances and questions that arise regarding a specific device or device type.  
 
 
59 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act. For devices that are class I or II and 
exempt from premarket notification (e.g., shoe covers, face shields), no 510(k) submission is required unless the 
limitations of exemption are exceeded (see, e.g., 21 CFR 878.9). 
60 This includes a marketing submission for the device within the scope of the guidances in List 1, or a marketing 
submission for a device that is a derivative of, or the next generation of, the device within the scope of the guidances 
in List 1. 
61 Manufacturers that do not have an accepted marketing submission before the start of Phase 3 should refer to the 
policy described in Section V.A. of this guidance. 
62 See footnote 36. 
63 For example, if a manufacturer made modifications to the labeling of a cleared fetal doppler as described in the 
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring 
During the COVID-19 Public Health Emergency guidance, FDA generally does not intend to object to the 
manufacturer not complying with applicable labeling requirements (see 21 CFR Part 801) where the device 
continues to be labeled as described in that guidance while the marketing submission for the modified device is 
under review. 
64 Based on comments received on this draft guidance, as well as the companion transition guidance, FDA 
understands that updating the labeling of these devices while they are under FDA review, and then again if they are 
subsequently cleared, approved, or authorized, would be challenging for manufacturers. This policy takes those 
comments into account and is least burdensome for manufacturers and FDA. As noted elsewhere, manufacturers 
should engage with the Agency if they have questions specific to their device (e.g., regarding updating the device 
labeling to acknowledge that the device is currently under FDA review when the FDA review is expected to take an 
extended period of time).  
16  Contains Nonbinding Recommendations 
 
 
 
The enforcement policy in this section (Section V.D.(1)) relates to FDA marketing authorization 
(e.g., 510(k) clearance), and certain UDI and other applicable labeling requirements. It does not 
apply to other legal requirements (such as registration and listing,65 QS, and reports of 
corrections and removals requirements under 21 CFR Parts 807, 820, and 806, respectively) that 
may apply.66 Moreover, it does not apply after FDA has taken a final action on the marketing 
submission for a device. At that time, FDA expects manufacturers to comply with all applicable 
regulatory requirements for the device/manufacturer. Following the devices marketing 
authorization, this includes labeling updates (see 21 CFR Part 801), compliance with UDI 
requirements (see 21 CFR Part 801 Subpart B and Part 830), and any applicable updates to 
registration and listing information, including the submission number (see 21 CFR Part 807 
Subparts B-D). After marketing authorization, manufacturers also should follow the steps 
outlined in their Transition Implementation Plan. 
 
In addition, and as always, FDA will make case-by-case decisions regarding the enforcement of 
legal requirements in response to particular circumstances and questions that arise regarding a 
specific device or device type. This may include FDA requesting a firm initiate a recall (see 21 
CFR 7.45)67 or taking other actions, including an enforcement action. Moreover, FDA may 
revise the enforcement policies and recommendations in the guidance, as appropriate. 
 
As mentioned previously, FDA recommends that marketing submissions include in the cover 
letter a statement that the device is/was distributed as described in an enforcement policy, and 
submission number(s) for related premarket submissions. This information will help FDA track 
devices that are transitioning to the required marketing authorization,68 facilitate review of the 
submission, and help ensure that transitioning devices can be appropriately considered in light of 
the policy described in this section (Section V.D.(1) of this guidance). The marketing submission 
should be administratively complete in that it includes all of the information necessary for FDA 
 
 
65 For manufacturers that register and list by the start of Phase 2, FDA recommends that manufacturers utilize the 
term enforcement in the premarket submission field if a submission number is not yet available. If the device 
subsequently receives marketing authorization, FDA expects manufacturers to comply with all applicable 
registration and listing requirements, which may require updating the listing information. 
66 For more information regarding FDA regulatory requirements for a specific device and FDA policies related to 
those requirements, manufacturers can use the FDA Guidance Search Tool. to identify relevant guidance documents. 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/. After the start of Phase 3, FDA will 
look to any other applicable compliance policies and otherwise apply our general risk-based approach in making 
compliance and enforcement decisions. For more information, see the guidance Factors to Consider Regarding 
Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-regarding-benefit-
risk-medical-device-product-availability-compliance-and. 
67 21 CFR 7.45(a) states that FDA may request a firm to initiate a recall when the following determinations have 
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer 
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect 
the public health and welfare. 
68 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act. 
17  Contains Nonbinding Recommendations 
 
 
to conduct a substantive review.69 FDA understands there may be extenuating circumstances that 
may make doing so difficult (e.g., ongoing clinical trial or longer term non-clinical studies). 
Manufacturers in such circumstances should engage with the Agency early in the transition 
period.70 
 
In addition, during this transition period and after the start of Phase 3, FDA may receive 
questions from stakeholders (e.g., other Agencies, governmental stockpilers, healthcare 
providers) about a devices regulatory status for devices distributed as described in this section 
(Section V.D.(1)) while the marketing submission is under review by FDA. Typically, if a device 
has an EUA or conventional marketing authorization (e.g., 510(k) clearance), this information 
would be publicly available. The existence of a marketing submission under review is not 
typically disclosed unless certain circumstances apply, such as when the device is on the 
market.71 As such, for devices distributed as described in this section, FDA may share that a 
manufacturer is distributing such device as described in the policy in this guidance, which could 
indirectly reveal that the manufacturer has a marketing submission under review by FDA.72 
 
(2) Recommendations for Transition Implementation Plan 
FDA anticipates that some marketing submissions will include changes or updates to the device 
and/or its labeling compared to the product that was distributed as described in the relevant 
guidance in List 1. For example, a manufacturer may have distributed fetal dopplers as described 
in an enforcement policy, and the manufacturer intends to submit a marketing submission for 
such fetal dopplers with an additional, new indication. In addition, in some cases, a manufacturer 
may not receive a positive decision from FDA on its marketing submission.  
 
To help address all of these situations efficiently, FDA recommends manufacturers include in the 
cover letter of their marketing submissions a Transition Implementation Plan that addresses the 
manufacturers plans for dealing with devices already distributed in the case of a positive 
decision as well as in the case of a negative decision on the marketing submission. To the extent 
the Transition Implementation Plan contains trade secret information or confidential commercial 
or financial information, FDA will handle that information in accordance with applicable laws, 
including 21 CFR 20.61.  
 
 
69 For more information regarding FDAs acceptance policies for marketing submissions, see the guidances Refuse 
to Accept Policy for 510(k)s, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/refuse-accept-policy-510ks, Acceptance and Filing Reviews for Premarket Approval Applications 
(PMAs), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-and-
filing-reviews-premarket-approval-applications-pmas, and Acceptance Review for De Novo Classification 
Requests, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-
review-de-novo-classification-requests. 
70 FDA recommends that manufacturers engage with the Agency through the Q-Submission Program, including 
requesting Pre-Submissions, to discuss extenuating circumstances. For details on the Q-Submission Program, refer 
to the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program. 
71 See, e.g., 21 CFR 807.95(a)(1). 
72 To the extent the marketing submission contains trade secret information or confidential commercial or financial 
information, FDA will handle that information in accordance with applicable laws, including 21 CFR 20.61. 
18  Contains Nonbinding Recommendations 
 
 
 
FDA recommends the Transition Implementation Plan include the following information, as 
applicable:73 
 
  Estimated number of devices that fall within the policies outlined in any of the 
guidances referenced in List 1 above that are currently in U.S. distribution; 
  An explanation of the manufacturers benefit-risk based plan for disposition of already 
distributed product in the event of a negative decision on the marketing submission. If 
the manufacturer is proposing to leave already distributed product in place, the plan 
should address the rationale for doing so and considerations such as the following, 
where relevant:74 
  Process for notifying patients, consumers, healthcare facilities, healthcare 
o
providers, and device distributors of the devices regulatory status; 
  Process and timeline for restoring already distributed devices to an FDA-cleared 
o
or -approved version; 
  Process and timeline for providing75 a physical and/or electronic copy of updated 
o
labeling that accurately describes the product features and regulatory status (e.g., 
that the product lacks FDA clearance, approval, or authorization) for reusable 
devices. To help ensure accessibility to updated labeling for reusable life-
supporting/life-sustaining devices, FDA recommends that stakeholders be 
provided an opportunity to request a physical copy of updated labeling, and after 
such request, be provided the requested labeling without additional cost; and 
  A description of the maintenance plan for already distributed devices. 
o
  An explanation of the manufacturers plans for addressing already distributed product 
in the event of a positive decision on the marketing submission, including 
considerations such as the following, where relevant: 
  Process for notifying patients, consumers, healthcare facilities, healthcare 
o
providers, and device distributors of the devices regulatory status; and 
  Process and timeline for providing to users of already distributed devices updated 
o
labeling or components for the cleared or approved device, including updated 
labeling or components to reflect any cleared/approved changes to the already 
distributed device. 
 
 
 
73 If the manufacturer has already submitted a Notification of Intent with some of this information, FDA still 
recommends that manufacturers include a Transition Implementation Plan with their marketing submission, noting 
any updates since the Notification of Intent was submitted to FDA.  
74 While FDA recommends the inclusion of a benefit-risk based plan for disposition of already distributed product 
be submitted with a marketing submission for devices within the scope of this guidance, FDA also believes such an 
approach is consistent with device end-of-life best practices and recommends that manufacturers consider and 
conduct such activities even if the manufacturers Transition Implementation Plan is not prospectively shared with 
the Agency. 
75 The manufacturer should provide labeling to the original purchaser, and collaborate with the original purchaser to 
ensure that labeling is distributed to relevant stakeholders, including device distributors, healthcare facilities, 
healthcare providers, patients, consumers, etc. 
19  Contains Nonbinding Recommendations 
 
 
FDA encourages manufacturers to collaborate with device distributors, healthcare facilities, 
healthcare providers, patients, and consumers, as appropriate, regarding their Transition 
Implementation Plan to assist all stakeholders with transition planning. 
 
Depending on FDAs evaluation of the marketing submission, FDA may engage with the 
manufacturer during the Agencys review of the submission to discuss the appropriate 
disposition of already distributed devices described in the Transition Implementation Plan. For 
marketing submissions that include changes to the device compared to the already distributed 
device (e.g., modifications to address a cybersecurity concern), the manufacturer should discuss 
possible correction or removal with FDA regarding devices already distributed to the end user, as 
needed. As always, FDA will make case-by-case decisions regarding the enforcement of legal 
requirements in response to particular circumstances and questions that arise regarding a specific 
device or device type (e.g., requesting a firm initiate a recall (see 21 CFR 7.45),76 or taking other 
actions, including an enforcement action).  
 
E. Discontinuing distribution of a device 
FDA expects manufacturers to discontinue distribution of a device within the scope of this 
guidance: 
 
1)  Before the start of Phase 3, if the manufacturer has not submitted a required marketing 
submission77 for its device and had it accepted by FDA before the start of Phase 3; or 
2)  On the date the manufacturer receives a negative decision on its marketing submission 
as FDAs final action, or on the date the manufacturer withdraws its submission or 
fails to provide a complete response to an FDA request for additional information78 
within the allotted time identified in FDAs letter. 
 
In addition, manufacturers should be aware of any applicable legal requirements for their device, 
such as adverse event reporting under 21 CFR Part 803, and continue to comply with such 
requirements for the duration in which they are applicable, which may extend beyond the 
cessation of distribution.  
 
FDA encourages manufacturers to communicate with device distributors, healthcare facilities, 
healthcare providers, patients, and consumers, as appropriate, regarding their product disposition 
to assist all stakeholders with transition planning.  
 
 
 
76 21 CFR 7.45(a) states that FDA may request a firm to initiate a recall when the following determinations have 
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer 
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect 
the public health and welfare. 
77 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act. 
78 For more information on FDA requests for additional information (i.e., deficiency letters) and how to respond, see 
the guidance Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-
responding-deficiencies-accordance-least-burdensome-provisions. 
20  Contains Nonbinding Recommendations 
 
 
F. Quality System considerations 
FDA recognizes that there may be situations that raise unique compliance considerations, 
particularly regarding QS requirements. For example, non-traditional device manufacturers that 
previously operated under different quality standards or requirements may face challenges that 
take more time to address in transitioning to a system that fully complies with 21 CFR Part 820. 
FDA intends to take such considerations into account when making case-by-case compliance and 
enforcement decisions. Some manufacturers who intend to continue distributing their devices 
beyond Phase 2 may choose to request an exemption or variance from a device QS requirement 
as outlined in 21 CFR 820.1(e) and section 520(f)(2) of the FD&C Act. Any such exemption or 
variance should be requested within 90 days of the announcement of the implementation date for 
this guidance to help ensure FDA considers your request in time.  
 
VI.  Examples 
The following hypothetical examples are intended to illustrate the phased transition plan outlined 
above. To exemplify the timeline of the phased transition plan outlined in Section V. of this 
guidance, for purposes of the examples, FDA set the implementation date for all devices that fall 
within this enforcement policy as the implementation date, May 11, 2023, consistent with the 
timeline shown in Figure 1. The dates outlined in each example follow this example phased 
transition plan timeline. Note that these generalized examples do not account for every possible 
detail, risk, or consideration a manufacturer should evaluate or that may be relevant to FDA 
decisions regarding a particular device. 
 
  Example 1  
A 510(k)-cleared fetal doppler was modified to add Bluetooth functionality79 as described in the 
policies in the guidance, Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring 
Devices Used to Support Patient Monitoring During the COVID-19 Public Health 
Emergency.80   
 
a) Manufacturer who intends to continue distributing beyond 
Phase 2 and receives a positive decision on its marketing 
submission 
 
Phase 1 ( May 11, 2023): In the above-referenced guidance, FDA describes its intent not to 
object to modification of certain fetal dopplers in certain circumstances without marketing 
authorization by FDA. The enforcement policy in the guidance does not address other 
 
 
79 Manufacturers should also consult the guidance Multiple Function Device Products: 
Policy and Considerations, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/multiple-function-device-products-policy-and-considerations, for more information about how such a 
function can affect the regulation of a device. 
80Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-
invasive-fetal-and-maternal-monitoring-devices-used-support-patient. 
21  Contains Nonbinding Recommendations 
 
 
requirements, including adverse event reporting, reports of corrections and removals, and QS 
requirements. The manufacturer continues to comply with requirements under 21 CFR Parts 803, 
806, and 820. 
  
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the 
fetal doppler manufacturer updates its existing listing under 21 CFR Part 807 Subparts B-D, as 
applicable. On October 1, 2023, the manufacturer submits a marketing submission to FDA, 
which is accepted by the Agency. Along with its marketing submission, the manufacturer 
includes a Transition Implementation Plan for already distributed fetal dopplers in the case of a 
positive decision as well as in the case of a negative decision on the marketing submission. 
 
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180-
day transition period ends, and FDA has not yet taken a final action on the manufacturers 
marketing submission. Under these circumstances, FDA does not intend to object to the 
continued distribution of the fetal doppler before FDA takes a final action on the marketing 
submission (see Section V.D.(1) of this guidance). The manufacturer continues to comply with 
all other legal requirements applicable to the device (such as registration and listing, QS, and 
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806). 
Additionally, the manufacturer has kept the device labeling as described in the labeling 
recommendations provided in the above-referenced guidance. Under these circumstances, FDA 
does not intend to object to the device labeling not complying with applicable labeling 
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the 
relevant List 1 guidance while the marketing submission is under FDA review (see Section 
V.D.(1) of this guidance). 
 
The manufacturer receives a positive decision on its marketing submission on December 29, 
2023 (90 days after submission), although outstanding software anomalies were identified and 
modifications to the device were made during FDAs premarket review. Based on the Transition 
Implementation Plan included with the marketing submission, FDA is aware of the number of 
already distributed devices that may have these anomalies and engages with the manufacturer on 
how to address these issues with the already distributed devices and provide updated electronic 
labeling to the relevant stakeholders. The manufacturer initiates a correction to address the 
software anomalies in the fetal dopplers that were distributed prior to the positive marketing 
decision.  
 
Additionally, as part of its Transition Implementation Plan, the manufacturer updates its website 
to add the updated device labeling. All devices distributed after receiving the positive decision 
will have the updated labeling.  
 
b) Manufacturer who intends to continue distribution beyond 
Phase 2 and receives a negative decision on its marketing 
submission 
 
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object 
to modification of certain fetal dopplers in certain circumstances without marketing authorization 
by FDA. The enforcement policy in the guidance does not address other requirements, including 
22  Contains Nonbinding Recommendations 
 
 
adverse event reporting, reports of corrections and removals, and QS requirements. The 
manufacturer continues to comply with requirements under 21 CFR Parts 803, 806, and 820. 
  
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the 
fetal doppler manufacturer updates its existing listing under 21 CFR Part 807 Subparts B-D, as 
applicable. On October 15, 2023, the manufacturer submits a marketing submission to FDA, 
which is accepted by the Agency. Along with its marketing submission, the manufacturer 
includes a Transition Implementation Plan for already-distributed fetal dopplers in the case of 
a positive decision as well as in the case of a negative decision on the marketing submission. 
 
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180-
day transition period ends, and FDA has not yet taken a final action on the manufacturers 
marketing submission. Under these circumstances, FDA does not intend to object to the 
continued distribution of the fetal doppler before FDA takes a final action on the marketing 
submission (see Section V.D.(1) of this guidance). The manufacturer continues to comply with 
all other legal requirements applicable to the device (such as registration and listing, QS, and 
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806). 
Additionally, the manufacturer has kept the device labeling as described in the labeling 
recommendations provided in the above-referenced guidance. Under these circumstances, FDA 
does not intend to object to the device labeling not complying with applicable labeling 
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the 
relevant List 1 guidance while the marketing submission is under FDA review (see Section 
V.D.(1) of this guidance). 
 
The manufacturer receives a negative decision on its marketing submission on January 15, 2024 
(90 days after submission), due to outstanding software anomalies that were identified and could 
not be addressed by the manufacturer during FDAs premarket review. As described in the 
Transition Implementation Plan included with the marketing submission, the manufacturer 
initiates a correction to restore the fetal doppler to the FDA-cleared version. In addition, the 
manufacturer ceases distributing the modified device. 
 
  Example 2  
A FDA-cleared diagnostic x-ray system was modified to become portable and falls within the 
enforcement policy described in the guidance Enforcement Policy for Imaging Systems During 
the COVID-19 Public Health Emergency.81  
 
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object 
to modifications to certain imaging systems in certain circumstances without marketing 
authorization by FDA. The enforcement policy in the guidance does not address other 
requirements, including requirements in 21 CFR Parts 803, 807 Subparts B-D, 806, 820, and 
830. The manufacturer continues to comply with these requirements.  
 
 
81 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
imaging-systems-during-coronavirus-disease-2019-covid-19-public-health-emergency. 
23  Contains Nonbinding Recommendations 
 
 
 
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the 
portable x-ray system manufacturer updates its existing listing, under 21 CFR Part 807 Subparts 
B-D, as applicable. On September 29, 2023, the manufacturer submits a marketing submission to 
FDA, which is accepted by the Agency. In its marketing submission, the manufacturer includes a 
Transition Implementation Plan for already-distributed portable x-ray systems in the case of a 
positive decision as well as in the case of a negative decision on the marketing submission. 
 
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180-
day transition period ends, and FDA has not yet taken a final action on the manufacturers 
marketing submission. Under these circumstances, FDA does not intend to object to the 
continued distribution of the portable x-ray system before FDA takes a final action on the 
marketing submission (see Section V.D.(1) of this guidance). The manufacturer continues to 
comply with all other legal requirements applicable to the device (such as registration and listing, 
QS, and reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 
806). Additionally, the manufacturer has kept the device labeling as described in the labeling 
recommendations provided in the above-referenced guidance. Under these circumstances, FDA 
does not intend to object to the device labeling not complying with applicable labeling 
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the 
relevant List 1 guidance while the marketing submission is under FDA review (see Section 
V.D.(1) of this guidance). 
 
The manufacturer does not respond to a request from FDA for additional information within the 
specified timeframe identified in the Agencys deficiency letter. FDA issues a notice of 
withdrawal as the Agencys final action on the marketing submission on March 15, 2024. FDA 
and the manufacturer engage regarding the manufacturers Transition Implementation Plan to 
address already distributed devices. The diagnostic x-ray is a reusable, non-life-supporting/non-
life-sustaining device; as such, the manufacturer, following the Transition Implementation Plan, 
updates its website to accurately describe the product features and regulatory status of the 
already distributed, modified devices. FDA may request the firm initiate a recall of such devices 
in certain circumstances if a recall has not already been initiated (see 21 CFR 7.45). In addition, 
the manufacturer ceases distributing the modified device. 
 
  Example 3  
A FDA-cleared ventilator was modified to make material changes to components in the gas 
pathway to accommodate supplier shortages and falls within the enforcement policy described in 
the guidance, Enforcement Policy for Ventilators and Accessories and Other Respiratory 
Devices During the COVID-19 Public Health Emergency.82  
 
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object 
to modifications to ventilators in certain circumstances without marketing authorization by FDA. 
 
 
82 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus.  
24  Contains Nonbinding Recommendations 
 
 
The enforcement policy in the guidance does not address other requirements, including 
requirements in 21 CFR Parts 803, 807 Subparts B-D, 806, and 820, and 830. The manufacturer 
continues to comply with these requirements.  
 
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the 
ventilator manufacturer updates its existing listing, under 21 CFR Part 807 Subparts B-D, as 
applicable. On October 1, 2023, the ventilator manufacturer also submits an amendment to the 
manufacturers previously cleared marketing submission to the CDRH Document Control Center 
with Attention: Notification of Intent on the cover letter of the submission to describe the 
manufacturers intent to submit a marketing submission. This submission amendment includes 
the information outlined in Section V.C.(1) of this guidance. In its marketing submission that 
was accepted by the Agency on December 20, the manufacturer includes a Transition 
Implementation Plan for already distributed ventilators in the case of a positive decision as well 
as in the case of a negative decision on the marketing submission. 
 
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180-
day transition period ends, and FDA has not yet taken a final action on the manufacturers 
marketing submission. Under these circumstances, FDA does not intend to object to the 
continued distribution of the ventilator before FDA takes a final action on the marketing 
submission (see Section V.D.(1) of this guidance). The manufacturer continues to comply with 
all other legal requirements applicable to the device (such as registration and listing, QS, and 
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806). 
Additionally, the manufacturer has kept the device labeling as described in the labeling 
recommendations provided in the above-referenced guidance. Under these circumstances, FDA 
does not intend to object to the device labeling not complying with applicable labeling 
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the 
relevant List 1 guidance while the marketing submission is under FDA review (see Section 
V.D.(1) of this guidance). 
 
The ventilator manufacturer receives a positive decision on its marketing submission on January 
2, 2024. The manufacturer continues to distribute the modified ventilator with updated labeling. 
In addition, the manufacturer communicates with users of the modified ventilator, distributed as 
described in the above-referenced guidance, apprising them of the regulatory status of the device 
and providing updated electronic labeling. 
 
  Example 4 
A new telethermographic system that has not been FDA-cleared and is intended for adjunctive 
diagnostic screening by providing an initial body temperature assessment for triage use, falls 
within the enforcement policy described in the guidance, Enforcement Policy for 
Telethermographic Systems During the COVID-19 Public Health Emergency.83  
 
 
83 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health.  
25  Contains Nonbinding Recommendations 
 
 
a) Manufacturer who intends to continue distribution 
beyond Phase 2 
Phase 1 (May 11, 2023): In the guidance, FDA describes its intent not to object to the 
distribution and use of certain telethermographic system without submission of a 510(k), reports 
of corrections and removals, registration and listing, and compliance with the QS regulation and 
UDI, and other applicable labeling requirements in certain circumstances. The enforcement 
policy in the guidance does not address other requirements, including requirements in 21 CFR 
Part 803. The manufacturer continues to comply with 21 CFR Part 803.  
 
Phase 2 (August 9, 2023): As an indication of its intent to market its device beyond Phase 2, the 
telethermographic system manufacturer registers and lists, consistent with 21 CFR Part 807 
Subparts B-D, as applicable. On October 5, 2023, the manufacturer submits a marketing 
submission to FDA, which is accepted by the Agency. In its marketing submission, the 
manufacturer includes a Transition Implementation Plan for already distributed 
telethermographic systems in the case of a positive decision as well as in the case of a negative 
decision on the marketing submission. 
 
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180-
day transition period ends, and FDA has not yet taken a final action on the manufacturers 
marketing submission. Under these circumstances, FDA does not intend to object to the 
continued distribution of the telethermographic system before FDA takes a final action on the 
marketing submission (see Section V.D.(1) of this guidance). The manufacturer complies with 
all other legal requirements applicable to the device (such as registration and listing, QS, and 
reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806). 
Additionally, the manufacturer has kept the device labeling as described in the labeling 
recommendations provided in the above-referenced guidance. Under these circumstances, FDA 
does not intend to object to the device labeling not complying with applicable labeling 
requirements (see 21 CFR Part 801) where the device continues to be labeled as described in the 
relevant List 1 guidance while the marketing submission is under FDA review (see Section 
V.D.(1) of this guidance). 
 
The manufacturer receives a not substantially equivalent decision on January 3, 2024, after 
FDAs review of the manufacturers marketing submission. The manufacturer ceases distributing 
the telethermographic system. FDA and the manufacturer engage regarding the manufacturers 
Transition Implementation Plan to address already distributed devices. FDA may request the 
firm initiate a recall of such devices in certain circumstances if a recall has not already been 
initiated (see 21 CFR 7.45). 
 
b) Manufacturer who does not intend to continue 
distribution beyond Phase 2 
A new telethermographic system that has not been FDA-cleared and is intended for adjunctive 
diagnostic screening by providing an initial body temperature assessment for triage use was 
26  Contains Nonbinding Recommendations 
 
 
distributed under the enforcement policy described in the guidance, Enforcement Policy for 
Telethermographic Systems During the COVID-19 Public Health Emergency.84  
 
Phase 1 (May 11, 2023): In the above-referenced guidance, FDA describes its intent not to object 
to the distribution and use of a certain telethermographic system without submission of a 510(k), 
reports of corrections and removals, registration and listing, and compliance with the QS 
regulation, UDI, and other applicable labeling requirements in certain circumstances. The 
enforcement policy in the guidance does not address other requirements, including 21 CFR Part 
803. The manufacturer continues to comply with 21 CFR Part 803.  
 
Phase 2 (August 9, 2023): The manufacturer decides that it does not want to continue to market 
and distribute the device beyond Phase 2. The manufacturer ceases distributing the device on 
November 1, 2023. The telethermographic system is a reusable, non-life-supporting/non-life-
sustaining device. Devices that were distributed before the end of Phase 2 remain distributed. In 
addition, the manufacturer continues to report adverse events that it becomes aware of, even after 
the manufacturer has ceased distributing the telethermographic system. 
 
Phase 3 (November 7, 2023): The above-referenced guidance is no longer in effect after the 180-
day transition period ends. Prior to the start of Phase 3, the manufacturer provides updated 
electronic labeling for the telethermographic system, and such labeling accurately describes all 
product features and notes that the product is not FDA-cleared, -approved, or -authorized for 
marketing. The manufacturer leaves already distributed telethermographic systems in the field. 
The manufacturer continues to engage in adverse event reporting to FDA concerning the device.  
 
 
 
84 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-
telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health.  
27       
 
Table 2 . Summary of Recommendations for a Phased Transition 
PHASE  1  2  3 
STARTING  0 days (implementation  90 days after the implementation date  August 9.  180 days after the implementation date  November 7, 2023 
TIME  date  May 11, 2023)  2023 
ACTIONS  Manufacturers should, if  Before the start of Phase 2, manufacturers that  After the 180-day transition period ends, the List 1 guidances 
not already doing so,  intend to continue to continue to distribute their  containing COVID-19 related enforcement policies will no 
follow adverse event  devices after Phase 2 should register their  longer be in effect. 
reporting requirements  establishments and list their device(s), or update   
under 21 CFR Part 803.    their existing registration and listing, under 21 CFR 
Before the start of Phase 3, if manufacturers submit a 
Manufacturers should  Part 807 Subparts B-D, as applicable.   marketing submission(s), and that submission is accepted by 
submit any stored    FDA, at this time, FDA does not intend to object to the 
adverse event reports  Before the start of Phase 2, if not already doing so,  continued distribution of the device after Phase 2 as described 
and should refer to  manufacturers should submit reports of corrections  in Section V.D.(1) of this guidance. With the marketing 
applicable FDA  and removals consistent with 21 CFR Part 806  submission, the manufacturer should include a Transition 
guidance regarding  (regardless of whether they intend to continue  Implementation Plan that addresses the manufacturers plans 
adverse event reporting  distribution of their devices after Phase 2).  for devices already in distribution in the case of a positive 
during a pandemic.     decision or a negative decision on the marketing submission. 
  Manufacturers of devices under the product codes  FDA recommends that the Transition Implementation Plan 
Manufacturers that  listed in Table 1 of this guidance should send a  include the information in Section V.D.(2) of this guidance, as 
intend to continue  Notification of Intent to FDA (regardless of  applicable. 
distribution of their  whether they intend to continue distribution of their   
devices after Phase 2  devices after Phase 2).  Moreover, for devices for which FDA has accepted a marketing 
should begin to prepare 
  submission prior to the start of Phase 3, FDA does not intend at 
their required marketing 
Manufacturers that intend to distribute their devices  this time to object to the devices not complying with certain 
submissions.  after Phase 2 should continue to prepare to submit a  UDI and other applicable labeling requirements where they are 
marketing submission to FDA and have it accepted  labeled as described in the relevant List 1 guidance.  
by FDA before the start of Phase 3.   
This enforcement policy does not apply to other applicable 
legal requirements (such as registration and listing, QS, and 
reports of corrections and removals requirements under 21 CFR 
Parts 807, 820, and 806, respectively).  
 
28