Search Results
The default setting for search results displays All Content. If you prefer to see recent content only, please adjust the date filter.
Filter your results:
Types
Topics
3 Results Found
FDA Issues Final Rule to Regulate Laboratory Developed Tests as Medical Devices
The Food and Drug Administration (FDA) on April 29 issued a final rule that will phase out, over four years, its general enforcement discretion approach for in vitro diagnostic tests (IVDs), which include laboratory developed tests (LDTs).
AHA Statement on "Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule."
AHA statement before the House Committee on Energy and Commerce
Subcommittee on Health on the impact of the Food and Drug Administration’s (FDA) proposed regulation of diagnostic tests.