Speaking Engagements
EUAs, 510(k)s and De Novos Demystified: Bringing COVID-19 Tests to the U.S. Market
Medmarc: Risk Management Webinar Series
| Date: | November 16, 2022 |
| Location: | Webinar |
Jianlin Song (Partner-San Francisco, CA) co-presents “EUAs, 510(k)s and De Novos Demystified: Bringing COVID-19 Tests to the U.S. Market,” part of Medmarc’s Risk Management Webinar Series, on November 16, 2022. 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? Topics include 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; and the legal implications surrounding COVID-19 tests, including PREP Act involvement and sale under EUA.
More information is available on the event website.