Data / Federal rules / 2024-08934
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability
The Food and Drug Administration published this proposed rule in the Federal Register on May 6, 2024. Comments closed on July 5, 2024.
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What the agency says
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564." In the context of emergent situations involving chemical, biological, radiological, or nuclear (CBRN) threats, there may be a public health need for certain in vitro diagnostic devices (IVDs) to be available for immediate response purposes. When finalized, this guidance will describe the Agency's enforcement policy for certain laboratory manufacturers offering certain unauthorized IVDs for immediate response to CBRN agents in the absence of a declaration applicable to IVDs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance is not final nor is it for implementation at this time.
Key facts
- Document number
- 2024-08934
- Type
- Proposed rule
- Action
- Notice of availability
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- May 6, 2024
- Comments due
- July 5, 2024
- Dates
- Submit either electronic or written comments on the draft guidance by July 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Docket
- Docket No. FDA-2024-D-0083
- Code of Federal Regulations
- 21 CFR 809
- Pages
- 2
Other documents from the Food and Drug Administration
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