Division of Clinical Research

Office of the Vice President and Innovation

Summary: Following a recent court case, Genus Med. Techs., LLC v. FDA, it was determined that the FDA cannot classify products that meet the definition of devices as drugs as they have previously been doing with some imaging agents.  As a result the FDA will transition specific products being regulated as drugs to being regulated as devices.  The FDA is aiming to make this transition without disrupting the supply of the medical products or placing burdens on the product manufacturers or on the healthcare delivery system.

Read more here: https://www.raps.org/news-and-articles/news-articles/2021/8/after-court-defeat-fda-shifts-to-regulating-some-d?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%209%20August%202021

Categories Devices, Drugs and Biologics, FDA Regulatory

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