- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
This is a flexible document which represents the current major concerns and issues regarding in vitro diagnostic devices as based on recent scientific and clinical experience and on traditional submissions by manufacturers. As advancements are made in science and medicine, these review criteria will be evaluated and revised as necessary to accomodate new knowledge.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.