Distribution of IVD products for RUO and IUO-FDA Final Guidance

sreenu927

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#1
FDA has issued final guidance for In Vitro Diagnostic devices(IVD) to be properly labeled for use in research (RUO) and investigation (IUO) purposes.
The draft gudiance was issued in June 2011 and was named as,
"Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions".

Regards,
Sreenu
 

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