The FDA proposes 70 changes to the 510(k) process

FDA unveils proposed changes to 510(K) program (MassDevice) Medtronic, Stryker, J&J Face New U.S. Rules for Medical Device Approvals (Bloomberg) 510(k) premarket review process at FDA.gov (FDA)

a new class IIb will require clinical data some previous 510(k)s will be revoked FDA will hear feedback of proposed changes until early October...