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Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

Date: 26 September 2022
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In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.

Rebecca M. Schaefer
Rebecca M. Schaefer
Research Triangle Park
Michael H. Hinckle
Michael H. Hinckle
Research Triangle Park
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