Industry Lawyer Says FDA-Proposed Device Accessory List Too Short

An industry lawyer said a newly proposed list of device accessories that FDA thinks could be re-classified as low-risk does not fully embrace requests from industry and a directive from Congress to reduce the regulatory burden related to certain device accessories. Brad Thompson, a member of the firm at Epstein Becker Green, said the list only includes 10 categories of device accessories, nearly all of them in the fields of gastrology or urology. “Given the number of device categories that...