The federal government closed on February 9, 2010, due to major snow accumulations, but the Food and Drug Administration (FDA) persevered with its scheduled meeting to discuss how new science should be incorporated into regulatory decision-making. 

Jeff Shuren, MD, JD, the new Director of the Center for Devices and Radiological Health (CDRH) at the FDA, introduced the meeting, which he hoped would provide insight on how the agency might tackle certain challenges.  Dr. Shuren, Jonathan Sackner-Bernstein, MD, Associate Director for Postmarket Operations, and other CDRH staff interacted with a panel of invited discussants.

To instigate a meaningful dialogue, the FDA posed four case studies depicting scenarios that CDRH staff may confront in the areas of post-market information, changes in clinical science, technological improvements, and novel technologies.  For example, one question asked participants to consider when the agency receives new scientific information about a particular product, what should the criteria be for changing CDRH’s expectations of the evidence necessary for pre- or post-market regulatory decisions.  The agency also asked if new technology is presented when a device is under review, should any changes apply to like products already on the market.

The intent of the meeting was to obtain feedback on these topics, not to reach consensus or decisions.  A random sampling of the comments expressed during the five-plus hour meeting is summarized below:

FDA should be encouraged to develop more collaborative relationships.

Don’t be too quick to label a predicate device “obsolete.”  Even though improvements may be made, the original device may be useful for certain patients.

Excessively rigorous standards for novel technologies should not be imposed, especially if not imposed upon existing devices.  Consistency is important.

FDA might work cooperatively with the National Institutes of Health and others to take responsibility for some testing.

Risk-based decision making needs data sets, but often the data sets aren’t available.  An analysis of autopsy data may be useful to collect.

Concern was expressed over a desire to mandate too many rules in the pre-approval process.  FDA was encouraged to use other tools to achieve goals.

The agency was strongly urged to share potential device concerns with consumers and practitioners.

The health of the public must be paramount.

CDRH encourages written comments by February 24, 2010, on how it may incorporate these new science challenges into its regulatory decision-making processes.