CDRH Industry: Postmarket Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and FDA Staff

Today the FDA released a draft guidance document Postmarket Management of Cybersecurity in Medical Devices. This document details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.  It is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their life cycle, in the face of potential cyber threats.

Thank you,
Food and Drug Administration Center for Devices and Radiological Health