FDA releases new action plan looking to improve device cybersecurity, streamline approvals

FDA Commissioner Scott Gottlieb today released a statement laying out the federal watchdog’s plans for improving medical device regulation, including plans to improve cybersecurity and monitor the total product life cycles of devices. The announcement came as part of the FDA’s newly released  “Medical Device Safety Action Plan”. The plan focuses on five key areas, including improving medical device cybersecurity, integrating premarket and postmarket activities to monitor the total product lifecycle of products, establishing a medical device patient safety net in the US, exploring regulatory options to “streamline and modernize” implementation of postmarket mitigations and promoting safer medical device innovation, according to the FDA release. Gottlieb said that the FDA will seek additional funding and authorities from Congress related to medical device cybersecurity, and will also look for approval to establish a new CyberMed Safety Analysis board. The board would be a “public-private partnership to complement existing vulnerability coordination and response mechanisms and serve as a resource for device makers and the agency,” Gottlieb said in the release. In its move towards a “Total Product Life Cycle” approach to medical device management, the FDA said it will seek to guarantee that devices not only meet its “gold standard” for approval, but for the full life of the devices. “As we move to the TPLC...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Source Type: news