November 2, 2018 – Medical Design & Outsourcing – The U.S. FDA today announced a memorandum of understanding with the Department of Defense to accelerate regulatory assessment of medical products for military personnel.
Congress last year passed a law to expedite regulatory review of products to diagnose, treat or prevent serious diseases or conditions facing U.S. military personnel. The memorandum establishes a framework to implement the 2017 law. It allows the Secretary of Defense to request that FDA speed up the review of investigational submissions, applications for approval/licensure, and submissions for clearance for particular medical products.
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The increased collaboration between FDA and the military may actually prove to be good news for medical device safety, according to Madris Tomes, a former FDA analyst who is founder and CEO of medical device safety information software company Device Events.
