The Medical Device Innovation Consortium created "best practice" guidelines for developing and conducting Early Feasibility Studies in the United States. The purpose of Early Feasibility Studies involves offering earlier and broader access to medical technology while simultaneously encouraging device innovation.
Here are five things to know:
1. The draft guidelines offer insight on FDA and Insituional Review Board interactions, legal and IP considerations as well as patient perspectives of Early Feasibility Studies.
2. The blueprint serves as a supplement to the FDA's 2013 guidance on Early Feasibility Studies.
3. Of MDIC members surveyed in 2015, about half reported they didn't initiate Early Feasibility Studies in the last two years.
4. The survey found many companies wished to see documented success of U.S.-based Early Feasibility Studies before they conducted their own studies.
5. MDIC plans to incorporate comments into the final blueprint as well as prompt members to integrate the blueprint into their U.S.-based Early Feasibility Studies.
Download the draft blueprint here.