FDA grapples with home COVID-19 testing, moves forward with PreCert program

It's been turbulent times for the FDA. On the one hand, the U.S. regulator has found itself carefully unravelling its guidances to bolster COVID-19 testing and treatment – sometimes leading to confusion for companies searching for new ways to combat the global epidemic. On the other, the agency continues to push forward with broader initiatives to remap its processes so that novel software treatments won't be gummed up in regulatory red tape.

Each of these challenges was on full display over the past couple weeks. In today's HIMSSCast, host Jonah Comstock and MobiHealthNews Associate Editor Dave Muoio recap two major FDA stories on at-home COVID-19 testing regulation and the first digital therapeutic product to pass through the Software Precertification Pilot Program.

Articles mentioned in this episode:

EverlyWell, Nurx to release at-home COVID-19 test kits within a week

Scanwell Health, myLAB Box unveil more at-home COVID-19 testing services

At-home COVID-19 testing services pump the brakes after FDA warns of 'fraudulent' kits

FDA expands use of vital sign monitors to enable remote care, modifications during COVID-19 emergency

FDA clears Pear's digital insomnia therapeutic through 510(k), Pre-Cert pilot pathways

Q&A: A firsthand account of FDA's Pre-Cert Program