Recently, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) issued warning letters to medical device companies for improperly advertising and promoting their products in violation of the Federal Food, Drug and Cosmetic Act (FDC Act). The recent CDRH warning letters are another example of the agency’s efforts to play a more active role in reviewing promotional materials and, where applicable, issuing enforcement letters. CDRH continues to lap its drug compliance counterpart in the promotional enforcement area and has increased the number of personnel devoted to such review, and the recent issuances might signal more enforcement. In addition, these enforcement letters are posted on the FDA’s website and described in industry publications. CDRH is aware of the trickle-down elements that its enforcement activities will have. This Client Alert summarizes the recent warning letters issued by CDRH.
Click the link below to read the full alert.