# U.S. Food and Drug Administration **Acronym:** FDA **Entity class:** U.S. federal agency ## Definition The **U.S. Food and Drug Administration (FDA)** regulates medical devices and administers the federal premarket and postmarket framework that now makes cybersecurity a total-product-lifecycle obligation for covered cyber devices. ## Neurosecurity relevance Section 524B requirements place monitoring, vulnerability handling, exploit response, patches, updates, and [[wiki/Software Bill of Materials|SBOMs]] inside the medical-device lifecycle. This framework is the clearest current institutional substrate for extending cybersecurity from a networked implant toward the security of a complete [[wiki/Cyber-Biological System|cyber-biological system]]. ## Relationships - **lifecycle:** [[wiki/Medical Device Vulnerability Management|Medical Device Vulnerability Management]]. - **device class:** [[wiki/Brain-Computer Interfaces|Brain-Computer Interfaces]]. - **security field:** [[wiki/Neurosecurity|Neurosecurity]]. - **supply-chain record:** [[wiki/Software Bill of Materials|Software Bill of Materials]]. ## Sources / Provenance - U.S. Food and Drug Administration, [“Cybersecurity in Medical Devices Frequently Asked Questions”](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs), accessed 2026-09-23. **As of:** 2026-09-23