In mid-August, the U.S. Department of Health and Human Services (HHS) announced that FDA would no longer require premarket review of laboratory developed tests (LDTs) (tests designed, manufactured, and used within a single laboratory), absent future legislation or notice and comment rulemaking. On October 7th, FDA announced that it would no longer review emergency use authorization requests for LDTs. There are competing views about whether FDA had previously overstepped its authority over LDTs and whether these changes could cause unreliable tests, including COVID-19 tests, to enter the market. This webinar will examine the history of FDA’s LDT regulation, HHS’s legal authority for revoking FDA’s premarket review process, whether the HHS announcement followed proper administrative law procedures, the effect of the HHS and FDA announcements on FDA’s regulation of both COVID-19 and non-COVID-19 LDT tests and FDA’s future use of enforcement discretion generally, and the progress of pending diagnostic reform legislation.

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Alberto Gutierrez, Partner, NDA Partners LLC
Peter Lurie, Executive Director, Center for Science in the Public Interest
Tom Sparkman, Senior Vice President, Government Affairs and Policy, American Clinical Laboratory Association
Moderated by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC 

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