Webcast | Virtual
Event Title
Webinar - Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances
June 5, 2024
- Date:
- June 5, 2024
- Time:
- 1:00 PM - 2:00 PM ET
Summary
On June 5, 2024, the U.S. Food and Drug Administration (FDA) held a webinar to provide an overview of two draft 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:
- Reviewed the scope and key elements of each draft guidance.
- Provided responses to previously submitted questions.
Background
The draft guidance, Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564, when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). Submit comments under docket number FDA-2024-D-0083 at www.regulations.gov by July 5, 2024, to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
The draft guidance, Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency, when finalized, will describe the factors that FDA intends to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 This draft guidance encompasses considerations that could be applicable to enforcement policies for all test manufacturers, not only laboratory manufacturers. Submit comments under docket number FDA-2023-D-5365 at www.regulations.gov by July 5, 2024, to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Webinar Materials
The presentation, printable slides, and transcript are also available at CDRH Learn under "In Vitro Diagnostics."
If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.