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- FDA Webinar on LDT Enforcement Policy June 5
On June 5, the U.S. Food and Drug Administration (FDA) will host a webinar to provide an overview of two draft laboratory-developed test guidances:
- Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
- Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency
During the webinar, the FDA will:
- Review the scope and key elements of each draft guidance.
- Provide responses to previously submitted questions.
If you have questions that you wish to submit for possible discussion during the webinar, email CDRHWebinars@fda.hhs.gov. All questions must be received by May 24 to be considered for the discussion.