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