EUAs, 510(k)s and De Novos Demystified: Bringing COVID-19 Tests to the US Market

COVID-19 test developers and regulatory bodies rose to the challenge of quickly supplying the public with the tests necessary to determine infection status. However, many of these tests were brought to market via a regulatory pathway dependent on the COVID-19 public health emergency declaration. What happens to these tests once the public health emergency declaration expires?
In this webinar, viewers can expect to learn:
• The differences between the FDA pathways to market
• A basic primer on how in vitro diagnostic tests work
• The regulatory landscape surrounding COVID-19 tests
• The legal implications surrounding COVID-19 tests, including PREP Act involvement and sale under EUA