The US Food and Drug Administration (FDA) is teaming up with industry and non-profit organizations for a new Medical Device Innovation Consortium (MDIC) to advance tools for evaluating the safety, quality and efficacy of medical technologies.
The partnership was jointly established by the FDA and Minnesota-based trade association LifeScience Alley, with industry representatives from companies including: Abiomed, BD, Boston Scientific, CVRx, Medtronic, Cyberonics, and Immucor Gamma.
The MDIC is the first ever public-private partnership created with the sole objective of advancing medical device regulatory science. The intent is to be a national 501c(3) organization that operates in partnership with the FDA that creates a safe haven for pre-competitive collaborative research on medical devices between academia and industry.
The FDA hopes to utilize the consortium to improve the validation process for devices and to prioritize funding and regulatory science decisions. “For the first time, we can determine priorities, bring together collaborative minds and analyze post-market values to determine safety and efficacy,” stated Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health.
Unlike other countries that require only proof of safety for medical device approval, FDA standards also require demonstration of efficacy in treating a specific disease or medical condition. Making the approval process more efficient will lessen the lag time to bring devices to patients in the U.S.
Read more at the Medical Device Innovation Consortium website.
