FDA Medical Device Requirements: Necessary But Not Sufficient

Last month, the United States Food and Drug Administration (FDA) issued long-awaited guidance for properly securing medical devices. The new requirements include comprehensive plans for handling cybersecurity issues and adopting common practices like threat modeling before a device receives approval for public use.

administration cybersecurity cybersecurity issues device devices fda food food and drug administration guidance handling medical medical device medical devices modeling plans practices public requirements states threat threat modeling united united states