On January 19, 2011, FDA announced 25 actions that it intends to implement or begin implementing this year with regard to the 510(k) process (and associated action dates)—as well as 7 controversial proposals it has decided not to implement now, but intends to further consider. See FDA, 510(k) and Science Report Recommendations: Summary and Overview of Comments and Next Steps (510(k) Actions Report).i The actions announced are less sweeping than the 55 recommendations for the 510(k) process made by the agency’s internal 510(k) Working Group and Science Task Force and released in August 2010.ii FDA received public comments on those recommendations and states that its actions are in most respects consistent with the comments received.

The 25 actions FDA intends to adopt and related timelines are appended at the end of this Alert.iv These actions fall into three broad categories: guidance development, internal/administrative actions, and programmatic/regulatory initiatives. FDA states that the actions are intended to “support[] innovation, keep[] jobs here at home, and bring[] important, safe, and effective technologies to patients quickly.”v These goals were emphasized in a Wall Street Journal op-ed by President Barack Obama.vi In a January 19 press call, CDRH Director Jeff Shuren explained that the actions are also intended to enhance the consistency, predictability, and transparency of the Center’s 510(k) practices.

Please see full Alert below for further information.