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GUIDANCE DOCUMENT

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only Guidance for Industry and FDA Staff November 2013

Download the Final Guidance Document
Final
Docket Number:
FDA-2011-D-0305
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center 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).

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Submit Comments Online

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:

Dockets Management
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.

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