FDA Committee To Hold Meeting On Genetic Test For Opioid Use Disorder
The FDA will discuss the de novo request for opioid use disorder genetic test, AvertD.
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The FDA Clinical Chemistry and Toxicology Devices Panel voted 11-2 that the risks of AvertD’s genetic test for opioid use disorder outweigh the product’s potential benefits as a diagnostic.
In a 30 August guidance from the US FDA, the agency proposed support and guidance for medical device innovation to treat substance use disorder.
The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.