# Medical Device Vulnerability Management **Entity class:** Regulatory and security lifecycle ## Definition **Medical-device vulnerability management** is the total-product-lifecycle process for monitoring, identifying, disclosing, prioritizing, remediating, patching, and verifying cybersecurity weaknesses in connected medical devices and related systems. Section 524B of the Federal Food, Drug, and Cosmetic Act requires covered cyber-device submissions to include a postmarket vulnerability and exploit plan, processes providing reasonable assurance of cybersecurity, postmarket updates and patches, and an [[wiki/Software Bill of Materials|SBOM]]. This is the institutional foundation from which writable-interface security can extend into [[wiki/Neurosecurity|neurosecurity]]. ## Relationships - **regulator:** [[wiki/U.S. Food and Drug Administration|U.S. Food and Drug Administration]]. - **vulnerability data:** [[wiki/Common Vulnerabilities and Exposures|CVE]] and [[wiki/National Vulnerability Database|NVD]]. - **neural extension:** [[wiki/Bidirectional BCI Security|Bidirectional BCI Security]]. - **recovery:** [[wiki/Verified Neural Restoration|Verified Neural Restoration]]. ## 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), especially Q4 and Q8–Q9, accessed 2026-09-23. **As of:** 2026-09-23