Why this matters
Most fielded medical devices were not designed to meet the FDA's 2026 cybersecurity expectations. Pulling them all from the field is unrealistic; ignoring them is a regulatory and patient-safety risk. The middle path - structured remediation with compensating controls and honest customer communications - is what the FDA, hospitals, and patients expect.
Key takeaway: 'Legacy' is not a defense. The FDA expects manufacturers to actively manage cybersecurity risk for fielded devices throughout the total product lifecycle, regardless of when they were cleared.