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

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

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Language(s):
English
Format:
Text
Subject(s):
Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
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 recognizes that it will take time for device1 manufacturers, 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.” To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA’s general recommendations for a phased transition process with respect to devices that fall within certain enforcement policies issued during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. FDA is concurrently issuing a companion transition guidance to describe FDA’s recommendations for devices issued emergency use authorizations (EUAs) related to COVID19. The companion transition guidance does not include phases as described in this transition plan for devices that fall within enforcement policies and instead relies on the advance notice(s) of termination process required under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA believes that these transition guidances will help prepare manufacturers and other stakeholders for the transition to normal operations and foster compliance with applicable requirements under the FD&C Act and its implementing regulations. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (28 pages))
NLM Unique ID:
9918662283806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918662283806676