In an August 31, 2010 webinar, representatives from FDA's Center for Devices and Radiologic Health (CDRH) fielded questions concerning the reports with preliminary recommendations issued earlier this month by the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.  It is now midway through the 60-day comment period on these reports.  CDRH Director Dr. Jeffrey Shuren began the webinar by explaining some of the major recommendations and emphasizing that their intent is to streamline processes and bring greater consistency and transparency to CDRH decisions, while also offering greater protections for patients.  The full reports are available on the FDA website.  To view our earlier analysis, click here. 

Need for Change Challenged and Defended

Some questions challenged the need for change or expressed concern that the proposed changes will make the process for clearing medical devices so difficult that device innovation will be impeded and US patients will not have the benefit of new technology. 

CDRH representatives restated the agency's commitment to supporting innovation, as one of its three main purposes.  Many of the proposals were characterized as improving processes and communication, rather than changing the substantive principles that guide CDRH decisions.  However, CDRH also said the process for clearing and monitoring devices needs revision, particularly to reflect increased complexity and advancing science.  The same suite of industry concerns has been expressed before, in connection with the working group processes leading to the reports, and CDRH did not seem swayed by them today. 

The overall message from this afternoon was that, from CDRH's perspective, the recommendations strike the right balance between innovation and safety.    

Class IIB Not Designed to Increase Data Requirements

At one point in the afternoon, Christy Foreman, Acting Director of the Office of Device Evaluation, said it was not CDRH's intent to turn the world upside down for device manufacturers.  She offered assurance that the new proposed classification level IIB was designed primarily to bring greater transparency to CDRH's current practices and thinking, rather than to fundamentally change CDRH's view about what data are required.  The devices likely to be designated as needing clinical or manufacturing data per the new Class IIB are those, in most cases, for which CDRH already has been receiving such data.  Dr. Shuren also expressed this view, both in his introductory comments and in response to a question.  In addition, Ms. Foreman emphasized that a need for clinical data would not necessarily mean that a company must conduct a randomized, controlled clinical trial.  The term clinical data should be interpreted broadly to include a range of available information about experience in people.

In addition to the 30 days remaining for public comment on these reports, there will be new comment periods as CDRH outlines specific regulations to implement the recommendations.  Stay tuned.