Skip to main content
FDA Webinar: Enforcement Policies for Certain In Vitro Diagnostic Devices – Draft Guidances

The U.S. Food and Drug Administration (FDA) is announcing a webinar to discuss draft guidances:

  • Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564,when finalized, will describe the FDA’s enforcement policy for certain laboratory manufacturers offering certain unauthorized in vitro diagnostic devices (IVDs) for immediate response to chemical, biological, radiological, or nuclear (CBRN) agents in the absence of a declaration applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency,when finalized, will describe the factors that FDA intends to consider in determining whether to issue an enforcement policy regarding test manufacturers’ offering of certain devices, specifically unapproved tests, for the diagnosis of disease, or other conditions during a declared emergency. This draft guidance encompasses considerations that could be applicable to enforcement policies for all test manufacturers, not only laboratory manufacturers.

During the webinar, the FDA will provide an overview of these draft guidances and provide responses to previously submitted questions.

  • Webinar Date: Wednesday, June 5, 2024, from 1:00 PM – 2:00 PM ET
  • Location: webcast
  • Registration: Not required 

If you have questions about these draft guidances that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by May 24, 2024, to be considered for the discussion. Questions will not be taken during the live webinar.

If you have questions about this webinar, contact the Division of Industry and Consumer Education.

Tehelj