Wound Products, Antimicrobial Resistance, and Commercial Speech: FDA’s Solution in Search of a Problem By Jennifer D. Newberger —

https://www.thefdalawblog.com/2024/07/wound-products-antimicrobial-resistance-and-commercial-speech-fdas-solution-in-search-of-a-problem/?utm_source=rss&utm_medium=rss&utm_campaign=wound-products-antimicrobial-resistance-and-commercial-speech-fdas-solution-in-search-of-a-problem In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these wound products are some of the few remaining medical devices that have not yet been classified by FDA. As a result, they have been coming to market through the 510(k) process as Class II medical devices since passage of the Medical Device Amendments, nearly 50 years ago. While it is well within FDA’s right to formally classify the products, the position it is taking in the proposed rule is not based in science or evidence, and raises serious commercial speech concerns.