Take Care In Promoting Lab-Developed Genetic Tests Or Risk US FDA, FTC Ire
Device-practice attorneys provide tips and precautions for laboratories advertising and promoting non-cleared or unapproved molecular-based diagnostics, and avoiding enforcement.
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FDA recently sent untitled letters to three direct-to-consumer genetic testing firms asking them to seek clearance for their making medical claims.
ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.
The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.