Why this matters
The FDA's 2026 final premarket guidance requires a credible postmarket cybersecurity plan in the submission itself - including a Coordinated Vulnerability Disclosure (CVD) policy, monitoring approach, and patch cadence. Section 524B(b)(1) of the FD&C Act makes a 'plan to monitor, identify, and address postmarket cybersecurity vulnerabilities' a statutory submission requirement. This blueprint gives you the policy, the operating model, and the evidence reviewers and researchers expect.
Key takeaway: A CVD program is not a security.txt file. Reviewers, researchers, and hospital customers all want to see a policy, a working intake, real triage SLAs, and a track record of advisories - not just an email address.