Warren, Cassidy To FDA: How Will You Identify Device Remanufacturers?

Democratic presidential candidate Sen. Elizabeth Warren (D-MA) wants FDA to elaborate on how it will differentiate between device servicers and device remanufacturers and how it will promote compliance among those that consider themselves servicers but that are in fact remanufacturers. Warren and Sen. Bill Cassidy (R-LA) wrote to FDA Thursday (Oct. 17), a little more than two weeks after FDA’s self-imposed Sept. 30 deadline for publishing draft guidance on the difference between device services and remanufacturers. The agency has not...