FDA’s 2020 Device Budget Would Focus On Safety, Cybersecurity, Bringing Medtech 'Home'
US FDA intends to use device-center dollars in its fiscal year 2020 budget on medical product safety, bolstering cybersecurity, device oversight modernization, and an initiative called “Bring Medtech Manufacturing Home,” among other priorities.
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The agency is again trying to get extra funding in its budget for a cybersecurity information sharing portal in its proposed fiscal year 2020 budget. FDA says the approach will not only help mitigate cybersecurity risks in near-real time, but also help speed up device reviews.
US FDA wants to make significant changes to how mammographers interact with patients in terms of the information they share about the procedure and standards they will have to follow. The issue specifically addresses scenarios where patients with denser breast tissue may not be fully informed about the accuracy of their mammography tests. If the agency's proposal moves forward, it will be the biggest regulatory change for the mammography industry in more than two decades.
The current administration would use an additional $98m in congressional budget authority in the 2020 fiscal year for FDA’s medical device efforts to modernize its regulatory approach for technology development, to enable device safety issues to be monitored more closely, and to advance new approaches for regulating digital health technologies and breakthrough devices.