The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
As Congress drafts legislation to create a pathway for biogeneric approval, lawmakers should limit mandates that could hinder the FDA’s ability to make decisions about clinical trials and bioequivalence testing, Gregory Conko, a senior fellow at the Competitive Enterprise Institute, said at the Generic Pharmaceutical Association’s Annual Policy Conference. For instance, Congress should not mandate clinical trials but allow the FDA to decide on a case-by-case basis whether such testing is needed, he said. Giving the FDA discretion in this area will spur innovation and development of assays to prove bioequivalence.