Drug-Device Rules Could Give FDA Leg Up in Industry Fights

A new FDA plan to revamp—and in some cases, drop—rules on how to deal with overlapping drug, device, and biologic products could give the agency an upper hand when challenged over how it classifies them.

Proposed changes to “product jurisdiction” regulations the agency released May 15 would alter who can suggest how a proposed new medical product should be classified (as a drug, device, biologic, or combination of any) and get rid of an optional appeal process, among other things.

How a proposed product gets classified and which FDA office reviews it can mean a lot to pharmaceutical and device ...