- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products are properly labeled “for research use only” (RUO) or “for investigational use only” (IUO).
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-2011-D-0305.