This FDA final guidance (September 2023) establishes current cybersecurity requirements for medical device manufacturers, implementing legal mandates from the Consolidated Appropriations Act 2023 (Section 524B). The guidance specifies mandatory inclusion of software bill of materials (SBOM), vulnerability disclosure policies, and cybersecurity management plans in premarket submissions for devices with network connectivity or remote functionality. Manufacturers must establish processes for identifying, evaluating, and disclosing known and potential cybersecurity vulnerabilities to the FDA and relevant stakeholders. The cybersecurity management plan should address threat modeling, risk assessment, security design controls, and post-market monitoring strategies. The guidance demonstrates alignment with international standards including IEC 81001-5-1 (application of risk management to network security) and AAMI TIR57 (medical device security guidance), facilitating harmonized global regulatory compliance. Manufacturers should integrate cybersecurity considerations throughout the device lifecycle from design through post-market surveillance. The guidance represents current regulatory expectations and serves as the primary reference for FDA premarket submissions incorporating cybersecurity requirements. Compliance demonstrates manufacturer commitment to protecting patient safety and data integrity.