The FDA released two new documents aimed to clarify the process for clinical trial approval and establishing earlier clinical trial studies during device development. The FDA is currently searching for a small number of companies to in the pilot program. Jeffery Shuren, director of the FDA’s CDRH, stated that earlier studies in investigational devices will expedite the process and get the device to the market sooner as well as spur innovation. At Pearl IRB, we have noticed an increase in FDA requirements for clinical trials for 501k products, even those who’s predicates have not been asked to do clinical trials previously.
The first document, FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, can be found here and the second document, Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies, can be found here.