FDA Requirements for Sponsor-Investigators


The FDA has a complex and extensive set of requirements for sponsor-investigators (investigators who hold an IDE or IND). MICHR has developed training to initiate new sponsor-investigators to these responsibilities and assist them in compliance. An introduction to the FDA requirements is available in this recent presentation.


IND-IDE Overview.pdf

The following links provide information about FDA regulations regarding investigational products.

FDA 21 CFR Part 312 – Investigational New Drug Application

FDA CRF Part 812 – Investigational Device Exemptions

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