Final Rule on IVDs Issued, Along with Two Guidance Documents
FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here). This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023. FDA explains that since “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]
