The Regulatory Landscape of Laboratory Developed Tests (LDT): A Laboratorian Perspective
Update: 2023-11-14
Description
The FDA released a proposed LDT rule and stated it will “end its enforcement discretion” of LDTs. Previously, the FDA explored other avenues for regulating LDTs. We will discuss questions relevant to the draft rule and implications to laboratory medicine, including, but not limited to:
- What are possible implications of FDA regulation of LDTs?
- Is the FDA the appropriate mechanism for this LDT oversight?
- What about modernization of CLIA?
- What would be the financial cost?
- What would be the diagnostic cost?
- What are possible implications of FDA regulation of LDTs?
- Is the FDA the appropriate mechanism for this LDT oversight?
- What about modernization of CLIA?
- What would be the financial cost?
- What would be the diagnostic cost?
Comments
In Channel
Download from Google Play
Download from App Store
United States00:00
00:00
x
