The Food and Drug Administration has announced a new project that aims to leverage the cybersecurity of medical technologies, FedScoop reported Friday.The Medical Device Safety Action Plan will rely on the FDA’s previous rules around digital devices, as well as add industry experts onto the CyberMed Safety Analysis Board to assess the safety standards of medical products.
The plan also requires devicemakers to install a software patch, update capabilities and a “software bill of materials†in their products to encourage the FDA to modify its premarket guidance.
Aftin Ross, senior project manager at the FDA’s Center for Devices and Radiological Health, said the action plan aims to help devicemakers respond quickly to product issues.
Ross added that the new guidance will simplify the 806 existing reporting regulations which require device makers to report an issue and its consequences to the FDA within 10 days of its discovery.
President Trump allocated funds for the CyberMed Safety Analysis Board in his 2019 budget request to boost the FDA’s Expand the Digital Technology Industry program.
