September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.