aportes a la gestión necesaria para la sustentabilidad de la SALUD PÚBLICA como figura esencial de los servicios sociales básicos para la sociedad humana, para la familia y para la persona como individuo que participa de la vida ciudadana.
sábado, 16 de diciembre de 2017
FDA Draft Guidance on Investigational In Vitro Diagnostics (IVDs) Used in Clinical Investigations of Therapeutic Products
To: All registered in vitro diagnostic (IVD) manufacturers and importers
Subject: FDA Draft Guidance on Investigational In Vitro Diagnostics (IVDs) Used in Clinical Investigations of Therapeutic Products
describes when Investigational Device Exemption (IDE) regulation may apply to certain clinical investigations of therapeutic products;
describes certain regulatory requirements sponsors should be aware of as they develop and conduct investigations;
provides recommendations for determining the risk of investigational in vitro diagnostics (IVDs);
provides recommendations for institutional review boards (IRBs) in reviewing such investigations; and
provides recommendations for content to provide in an IDE application, when required.
The FDA believes sharing this information will assist manufacturers using investigational IVDs in clinical investigations of therapeutic products and IRBs that review such investigations in complying with the IDE regulation.
We welcome your comments and suggestions regarding investigational IVDs used in clinical investigations of therapeutic products.
The comment period for the Federal Register notice will be open for 90 days. Please submit comments no later than March 19, 2018. Instructions for submitting comments can be found in the Federal Register under docket number FDA-2017-N-6356.
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