The Medical Device Innovation Consortium developed a blueprint for early feasibility study success.
The MDIC, which was founded in 2012, is the first public-private partnership that aims to advance medical device regulatory science through the total product life cycle.
The draft contains best practice guidelines for planning and executing U.S.-based early feasibility studies. Topics discussed include interactions with the FDA and institutional review boards, legal and intellectual property considerations and patient perspectives on early feasibility studies.
"MDIC was founded to do exactly this kind of work, recognizing a strategic need to advance medical device regulatory science in a particular area and developing tools to make that happen. We will continue work to advance regulatory science with tools such as the EFS blueprint," said President and CEO of MDIC Bill Murray.
With the draft of the blueprint now released, the MDIC plans to integrate comments into a final blueprint later this summer and encourage members to use the blueprint in their own U.S.-based Early Feasibility Studies.
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