Postmarket Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Resumen

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Postmarket Management of Cybersecurity in Medical Devices." This draft guidance informs industry and FDA staff of the Agency's recommendations for identifying, addressing, and monitoring cybersecurity vulnerabilities and exploits for postmarket management of medical devices. This draft guidance is neither final nor is it in effect at this time.