Device Reuse: 510(k) Exemptions Terminated, Validation Guidance Awaited
FDA is retaining its 510(k)-exempt status for non-electric biopsy forceps, despite a further layer of scrutiny afforded by the Medical Device User Fee & Modernization Act
FDA is retaining its 510(k)-exempt status for non-electric biopsy forceps, despite a further layer of scrutiny afforded by the Medical Device User Fee & Modernization Act