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.
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.