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

...