Can those who routinely do studies with IVDs (e.g., research hospitals) use a general informed consent to address future studies using samples collected in their own facility?
To fulfill FDA informed consent requirements for studies of IVDs, a site may develop an informed consent process to address the use of samples collected at the facility (see the Glossary for definition) in a specific study or for a broader category of future studies. This general informed consent process may be used for subjects seen at and/or admitted to a specific facility. The informed consent document must contain all of the required elements found in 21 CFR 50.25.
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