The Impact of the FDA's Recent Shift on COVID LDTs and Beyond

In late November, the U.S. Department of Health and Human Services (HHS) withdrew a policy regarding laboratory developed tests (LDTs) established during the Trump Administration that directed the FDA not to enforce premarket review requirements for LDTs. While the policy was initially established to allow new COVID-19 tests to reach consumers more quickly, the FDA contended the rule limited its ability to address certain problematic tests.

However, this sudden shift has left laboratories developing new COVID tests with more questions than answers regarding the steps that now must be taken to receive Emergency Use Authorization (EUA) for their LDTs prior to clinical use.

During this webinar, we will welcome Gail H. Javitt, Director, Hyman Phelps & McNamara, P.C., to discuss:

• The implications of the FDA’s recent policy shift.
• How the EUA process for COVID LDTs is impacted.
• How this regulation could affect other LDTs moving forward.

  • Business & finance
  • Professional development
  • Science & tech
  • Categories:
    • Business & finance
    • Professional development
    • Science & tech
  • Duration: 1 hour
  • Price: Free
  • Language: English
  • Who can attend? Everyone
  • Dial-in available? (listen only): Yes.
  • Dial-in Number: Please register for this Webinar to view the dial-in info.
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