FDA has announced a new deadline of March 9, 2012, for submission of public comments regarding its draft guidance entitled, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations”, which was originally published in the Federal Register on November 10, 2011. The draft guidance explains the types of determinations FDA is empowered to make concerning new IDE applications, amendments and supplements. It also clarifies the circumstances under which clinical investigations of a significant risk device may begin without full approval. Researchers and administrators are encouraged to review this document, along with their institution’s current policies and procedures on research with investigational devices, even if they do not intend to submit comments. More information is available at FDA’s website.
