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Triage: Rapid Legal Lessons for Busy Health Care Professionals is a podcast created by the K&L Gates health care practice group to inform our clients and friends of the firm about the latest developments in health law. If you would like to provide feedback or would like to suggest a topic for a future episode of Triage, please contact usUse the icons below to subscribe to Triage via your favorite podcast app to have our episodes delivered directly to you as they become available.

Sep 26, 2022

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.