The Food and Drug Administration’s Medical Device Safety Action Plan includes several proposals that would enhance the safety of medical devices, some of which will require Congressional approval, GovInfoSecurity reports. FDA Commissioner Scott Gottlieb said, "Although medical devices provide great benefits to patients, they also present risks. With FDA's plan, we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers." In addition to the proposals, the FDA said it is exploring the development of the CyberMed Safety Expert Analysis Board, a public-private partnership aimed at addressing vulnerabilities and evaluating patient safety risk and that acts as a resource for device makers.
Full Story