FDA will host a webinar to discuss Cybersecurity quality system considerations on Tuesday, June 14, 2022, from 1 p.m. to 2:15 p.m. EDT. The webinar will focus on the latest and current Cybersecurity Premarket Submissions draft guidance released in April 2022. This draft guidance replaces the 2018 draft version and is intended to further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the Total Product Life Cycle, and to outline more clearly the FDA’s recommendations for premarket submission content to address cybersecurity concerns.
Download the guidance: Premarket-Cybersecurity-Guidance-draft-2022
