For a summary of the conference, as well as full audio of the event, please click here.
The U.S. Food and Drug Administration, or FDA, promotes public health by ensuring that marketed medical devices are safe and effective, and by facilitating the delivery of cutting-edge products into patient care without unnecessary delay. Currently, FDA reviews all high-risk devices (with the exception of Humanitarian Device Exemptions) according to the same standard of safety and effectiveness.
Recently, FDA's Center for Devices and Radiological Health, or CDRH, decided to explore whether some data currently collected before device approval could be collected postmarket, to speed patient access to devices that fill an unmet medical need. The center's 2014 strategic priorities document proposed the data shift to “strike the right balance between premarket and postmarket data collection.” In an article in The Gray Sheet, CDRH director Jeff Shuren explained that the proposed change would incorporate aspects of the center's prior innovation pathway pilots.
On Jan. 30, 2014, The Pew Charitable Trusts held a meeting titled “Patient Access to High-Risk Devices for Unmet Medical Needs.” Stakeholders discussed FDA's current regulatory authority and whether new approaches were needed to facilitate patient access to high-risk medical devices for serious, unmet medical needs. The conference drew more than 100 participants representing manufacturers, providers, payors, patients, and other health stakeholders.
Shuren delivered the keynote address, followed by two panel discussions moderated by Allan Coukell, Pew's senior director of drug and medical device initiatives, and two panels moderated by Josh Rising, Pew's director of medical devices. To examine the potential shift of some premarket evidence collection to the postmarket setting, the panels focused on the following questions: