Site icon Facet Life Sciences

Are You a Drug or Device?

Are You a Drug or Device?

Unseen Regulatory and Intellectual Property Impact of Genus

Regulatory history was made on 9 August 2021 in a Federal Register notice (Docket No: FDA-2021-N-0843) announcing that in accordance with the Genus decision, FDA intends to regulate products that meet both drug and device definition as medical devices, except where the statute indicates that Congress intended a different classification.

What’s more, FDA also plans to review all FDA-approved imaging agents and potentially reclassify them as drugs or devices according to whether they achieve their primary intended purpose through chemical action or are dependent on being metabolized for the achievement of their primary intended purpose.  This means that some currently approved imaging agents regulated as drugs will transition to be regulated as medical devices!

About Facet Life Sciences

Facet Life Sciences is the leading provider of innovative development solutions (software and services) designed to help small teams get to and through the FDA©. Our Product Development Champions deliver expert nonclinical, CMC, and clinical regulatory services using cutting-edge technologies that speed product R&D efforts. Facet teams create and manage critical development documentation for some of the industry’s fastest growing, most innovative life sciences companies.


Exit mobile version