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
2 Results Found
FDA Rescinds the Laboratory Developed Test Final Regulation
The AHA appreciates that the FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care.
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).