Industry Lawyers: FDA Combo Product Jurisdiction Rule Skirts Key Issues

By David Roza / May 22, 2018 at 2:53 PM
Device industry lawyers say a rule proposed by FDA May 15 to revamp how the agency classifies combination products, while including some beneficial changes, doesn't fix fundamental problems that make the process frustrating for industry. Those problems include a strict 15-page limit on requests for designations, which they say precludes sponsors from making convincing arguments for designating a product in a certain way; a lengthy review process where FDA’s Office of Special Medical Programs (OSMP) does not have a deadline...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.