USA – Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers

This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement discretions. The authors emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.

Introduction
Historically, the US Food and Drug Administration (FDA) has played an important role in the nation’s pandemic responses.  However, public and industry have witnessed an unprecedented level of involvement in medical-device policymaking from the FDA in response to the current COVID-19 pandemic.

The first case of 2019 novel coronavirus (2019-nCoV) infection was confirmed in the US on 20 January 2020. By 30 January,  a total of 9,976 cases had been reported in at least 21 countries.1 As a result of the confirmed cases of 2019-nCoV, the US secretary of Health and Human Services (HHS), Alex M. Azar II, determined on 31 January that, pursuant to section 319 of the Public Health Service (PHS) Act, there was a nationwide public health emergency.2 Subsequently, on 4 February, the secretary issued a separate determination and declaration that, pursuant to his authority under section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act, the public health emergency had significant potential to affect national security or the health and security of US citizens living abroad.3

After the issuance of several emergency use authorizations (EUAs), the FDA issued its first enforcement discretion guidance document on 20 March, in response to the COVID-19 emergency. Over the next 6 weeks, the agency issued a total of 15 guidance documents on enforcement policy for a number of device types.4 This article summarizes trends in FDA policies and regulatory considerations for medical device manufacturers when implementing such policies…