Federal Oversight of Laboratory-Developed Tests in Limbo 2021
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.
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