FDA and the Device Industry: Challenges in Working Together During the SARS-CoV-2 Pandemic

It has become common these days to hear “We live in unprecedented times.” The medical device industry and FDA have been at the forefront of working to combat the SARS-CoV-2 virus, through the development and authorization of diagnostic tests, personal protective equipment, ventilators, and more. However, the response to the virus has also changed the way that industry and FDA work with each other. While the Emergency Use Authorization (EUA) process potentially provides a way for industry to collaborate more closely with FDA, it also brings new challenges. This article is primarily focused on the in vitro diagnostics (IVD) industry, which accounts for the largest portion of the device EUA activities, but these concepts are also applicable to the medical device industry at large.

FDA has been working with EUA applications for emerging pathogenic diseases for quite some time and had developed a solid, reliable method for dealing with outbreaks. During previous emergencies, for example the 2016 Zika virus and 2014 Ebola virus outbreaks, FDA was able to seamlessly work its EUA efforts into the agency’s existing workload, and industry sponsors saw little, if any, impact to their pre-submissions, 510(k) and PMA applications. A total of 15 Zika virus assays and 10 Ebola virus assays were authorized under EUA.

In contrast, the unprecedented public health needs caused by the SARS-CoV-2 virus has led the diagnostic industry as a whole to focus a great deal of effort on the development of molecular, serology, antigen, and medical management tests for SARS-CoV-2 virus or antibodies to the virus and the symptoms associated with the COVID-19 disease. There has never been as much public and media focus on in vitro diagnostic testing than with the current pandemic. As of October 1, 2020, FDA has authorized over 200 diagnostic products related to COVID-19 under EUA. Based on information presented at weekly town halls hosted by Timothy Stenzel, MD, PhD, the FDA Office Director overseeing the regulation of IVD tests, FDA has received thousands of EUA applications and pre-EUA applications for COVID-19 diagnostics...