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FDA’s Cybersecurity Premarket Draft a Significant Rewrite

The FDA has reissued draft guidance for premarket cybersecurity considerations four years after the previous draft guidance, and eight years after the issuance of the most recent final guidance. While this draft guidance is not the final word on this policy, we would advise our clients that it represents a fundamental shift in the agency’s approach to cybersecurity, one that comes with a substantially more demanding set of requirements in the premarket phase of device development.