Federal Oversight of Laboratory-Developed Tests in Limbo: What’s the Regulatory & Legislative Outlook for LDTs?


Instructor: Dennis Weissman
Product ID: 706769
Training Level: Intermediate

  • Duration: 60 Min
This webinar will discuss the current status and outlook for federal oversight of Laboratory Developed Tests (LDTs) amid bureaucratic infighting during the COVID-19 pandemic regarding the authority of the Food & Drug Administration (FDA) to regulate LDTs.
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Why Should You Attend:

Though LDTs remain subject to the Clinical Laboratory Improvement Amendment (CLI A) requirements, the current uncertainty regarding FDA’s role in regulating LDTs raises the stakes for legislative reform. Pending legislation which would allow the FDA to maintain oversight of all diagnostics including LDTs while setting regulatory requirements based on a test’s risks, not where it was made will be detailed in this presentation.

Areas Covered in the Webinar:

  • Overview of Laboratory Developed Tests (LDTs)
  • FDA’s position for regulating LDTs including its handling of Emergency Use Authorizations (EUAs) for lab developed COVID tests.
  • Why an HHS decision that FDA not require pre- market review of LDTs absent notice-and-comment rulmaking
  • raises key questions about future oversight of LDTs.
  • Pros & cons of having CLIA as sole oversight of LDTs
  • Differing legislative approaches for determining the role of CLIA and FDA in regulating LDTs
  • Key features of VALID and VITAL Acts and industry reaction
  • Outlook for pending legislation relating to FDA oversight by LDTs
  • Why current regulatory status of LDTs remains in limbo & timeline for clarification of FDA’s authority

Who Will Benefit:

  • Laboratory medical & administrative directors and managers in academic, hospital & research labs
  • President, CEOs, COOs, lab medical directors, administrative directors in independent labs
  • Chief compliance officers, General Counsel & VP and senior managers of regulatory affairs
  • General counsels & VP for Regulatory Affairs for commercial diagnostic tests manufacturers
Instructor Profile:
Dennis Weissman

Dennis Weissman
President, Dennis Weissman and Associates LLC

Dennis is President of Dennis Weissman & Associates, LLC, a consultancy which provides market intelligence, business leadership and public policy guidance and M&A advisory services to diagnostic and health care organizations & related interests. He previously founded and served as publisher of Washington G-2 Reports (now G2 Intelligence), an information company that reports on the U.S. clinical laboratory and pathology sectors. His expertise is in Medicare and national health care policies and trends as well as business and financial issues affecting the health care industry

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