The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health and health care.
The goal of the TAP Pilot is to reduce the time from concept to commercialization of medical devices by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
Wouldn’t you like to stop routine FDA inspections and forego pre-approval inspections?
As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.