The agency hopes the plan will spur more innovation for device safety, help identify safety risks earlier, and keep physicians and patients more informed.
“Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs,” FDA Commissioner Scott Gottlieb, MD, said in a statement about the program.
Here are five goals the agency seeks to achieve through the plan.
- Establish a robust medical device patient safety net in the U.S.
- Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
- Spur innovation toward safer medical devices
- Advance medical device cybersecurity
- Integrate the FDA Center for Devices and Radiological Health’s premarket and postmarket offices and activities to advance the use of a total product life cycle approach to device safety
To learn more about the action plan, click here.
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