Wikimedia, Bmramon Along with medical device companies and non-profit organizations, the US Food and Drug Administration (FDA) is taking part in a new public-private partnership, called the Medical Device Innovation Consortium (MDIC), which aims to develop better tools for evaluating medical technologies, and do so more quickly.
The MDIC will “create a safe haven for pre-competitive collaborative research between academia and industry focusing on medical devices,” FDA commissioner Margaret Hamburg said at a press conference earlier this week (December 3), according to Spoonful of Medicine, a Nature Medicine blog.
Medical devices are often approved in Europe first, due to the FDA’s notoriously lengthy approval pathway, involving demonstrations of both safety and efficacy. (In Europe, developers must only show that a device is safe to gain regulatory approval.) The FDA hopes that the MDIC will help speed this process by allowing consortium members to share resources and prioritize time and money. “For the first time, we can determine priorities, bring together collaborative minds and analyze post-market values to determine safety and efficacy,” Jeffrey ...
