The FDA yesterday unveiled a plan containing 25 actions it intends to implement this year to improve the most common path to market for medical devices, the 510(k) process. Key actions include: streamlining the de novo review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process; and establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.(Medical Device Daily) Read More
