FDA Issues Premarket Guidance
Recommendations to Address Cybersecurity in Medical Devices
PITTSBURGH, PA, USA, September 27, 2023The United States Food and Drug Administration (US FDA) issued the final version of their guidance document titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – Guidance for Industry and Food and Drug Administration Staff” on September 27, 2023 (referred to as Premarket Guidance or the guidance in this summary). This important guidance...