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.
Now that CBER’s all-electronic Direct Recall Classification (DRC) program has been extended to non-blood products, problems with biologic drugs flagged in electronic biological product deviation reports (eBPDRs) may trigger recalls of those products under the program. No such recalls have yet been triggered, as the DRC system is not yet capable of processing eBPDR reports for non-blood products, Sharon O’Callaghan, a CBER compliance and quality officer and manager of the center’s eBPDR program, said. Washington Drug Letter