FDA to implement or reach a major milestone this year (2011) for forty-two of its prior fifty-five 510(k)-process recommendations

January 2011

In August 2010, FDA released for public comment a two-volume set of documents entitled “[CDRH] Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.  Volume I is entitled “510(k) Working Group Preliminary Report and Recommendations.” Volume II is entitled “Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.”

In the two volumes, the Working Group and the Task Force made fifty-five recommendations aimed at improving the 510(k) process, which is the most common path to market for medical devices.  After considering public comments received, FDA unveiled on January 19, 2011, a detailed report describing its game plan for addressing the fifty-five recommendations.

Here’s a recap of the plan:

• Twenty-eight of the recommendations received overall support from public comments.  Accordingly, FDA intends to promptly implement or reach a major milestone for these by the end of this calendar year 2011.

• Twelve of the recommendations received support with a caveat or modification.  Accordingly, FDA intends to promptly implement or reach a major milestone for these by the end of this calendar year 2011, taking the caveats and modifications into consideration.

• Fifteen of the recommendations were the subject of “significant concerns” raised during the now-closed public comment period.  For two of the fifteen, FDA intends to promptly implement or reach a major milestone by the end of this year 2011. Seven of the fifteen will be further reviewed by the nonprofit Institute of Medicine (IOM), whose feedback will be considered by the FDA in order to devise appropriate action items later.  Four of the fifteen will be addressed later via device-specific guidance on a case-by-case basis. The final two of the fifteen will be addressed later after additional stakeholder feedback is obtained via public meetings.

In total, 42 of the original 55 recommendations will be implemented or have major milestones this calendar year 2011.  Interestingly, the FDA work-plan for doing this has been distilled and presented as only 25 action items in FDA’s 2011 action plan summary.  Therefore readers are urged to be aware of the fact that 42 of the 55 recommendations are indeed represented in the 2011 campaign, not just 25 as could easily be concluded upon first glance at the action plan and FDA’s corresponding press release.

During the 2011 portion of the campaign, FDA is focusing on the actions that will have the greatest impact on the original goal of the 2010 recommendations (i.e., fostering medical device innovation, enhancing regulatory predictability, and improving patient safety).  Key examples include streamlining the de novo process, issuing guidance to provide greater clarity about the 510(k) program, improving training for CDRH staff and industry, making greater use of external experts, and making critical business process improvements in CDRH, such as establishing a Center Science Council.