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.
More articles on supply chain:
Medicare’s proposed drug pricing plan raises bipartisan concerns
Northwestern researchers: FDA faces room for improvement in regulation of female health devices
Physicians approve stroke prevention device for FDA approval after 13 years of research
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
