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Although loss of confidential health information is generally not considered to be a direct impact on safety and effectiveness, under Section 524B of the FD&C Act, a person who submits a 510(k), PMA, PDP, De Novo, or HDE for a device that meets the definition of a cyber device is required to submit information to ensure that cyber devices meet the cybersecurity requirements under section 524(b) of the FD&C Act

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