This post was written by Paul Sheives and Areta Kupchyk.

The Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has launched the Medical Device Innovation Initiative.  This program is designed to facilitate patient access to transformative innovative devices, which historically have been slow to obtain market approval or clearance because of the scientific and regulatory challenges inherent in new technology. As part of the initiative, FDA released a report entitled “510(K) and Science Report Recommendations,” which follows the agency’s preliminary report and call for comment in August 2010.  The report lays out a plan containing 25 actions FDA intends to implement during 2011 to improve the 510(k) clearance process. The key actions include: (1) streamlining the “de novo” review process for certain innovative, lower-risk medical devices; (2) clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process; and (3) establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making. CDRH will hold a public workshop on the Innovation Initiative on March 15, 2011 in Maryland to seek input on challenges associated with incentivizing innovation and the proposed solutions. The meeting will also be available via webcast. Registration for the meeting closes March 4, 2011. FDA is also accepting written comments until March 15, 2011.