FDA unveils plans to boost innovation of medical devices
The US Food and Drug Administration (FDA) has announced a new programme to boost the innovation of safer medical devices and breakthrough technologies.
FDA commissioner Scott Gottlieb unveiled the Safer Technologies Program (STeP) in a press release issued yesterday, December 18.STeP will be implemented in parallel to the Breakthrough Technologies Program (BTP), which is designed to advance the development of products which treat life-threatening conditions. STeP will focus on developing new medical devices which do not qualify for the BTP but can bring about an improvement in safety standards.
Gottlieb said the plan would apply “principles and features of the BTP to devices with the potential for significant safety improvements as compared to available treatment or diagnostic options”. The FDA is to announce detailed measures next year.
The purpose of the BTP is to speed up the approval of devices designated as a breakthrough technology. This involves increased interaction between the FDA and the developers of a device, including “sprint discussions” which seek to achieve mutual agreement on specific issues concerning the device within 45 days.
Developers can also submit a fast-tracked pre-submission to the FDA seeking feedback on a breakthrough device.
Gottlieb said that if the same measures “could be applied to bring innovation to medical device safety for less serious conditions, the potential public safety impact could be tremendous.”
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