FDA Holds Public Hearing on New Science and Decision Making

The FDA held a hearing regarding the Center for Devices and Radiological Health's (CDRH) response to, and anticipation of, new or evolving scientific knowledge in regulatory decision-making. In recent months, CDRH has formed an internal Task Force on Utilization of New Science in Regulatory Decision-making, whose purpose is to propose systems that will allow CDRH to be "predictably adaptive" to new science, and to identify steps that CDRH can take to ensure its staff is aware of the cutting edge science required to make proper regulatory decisions.

Hanson Gifford, Partner at the Foundry (a medical device incubator), presented on behalf of MDMA. In his remarks, Gifford described the challenges faced by some small medical device companies and discussed issues such as the use of surrogate endpoints, Medical Device Reports, and how irrational changes in the regulatory framework could force smaller companies out of business.