MedTech Dive March 13, 2024
Nick Paul Taylor

The agency is providing information on cybersecurity requirements for companies seeking authorization of new devices.

Dive Brief:

  • The Food and Drug Administration has requested feedback on plans to add a new section to the premarket cybersecurity guidance finalized last year.
  • Through the planned update, which the FDA released Tuesday, the agency wants to provide information on the requirements that the Food and Drug Omnibus Reform Act of 2022 (FDORA) created for companies seeking authorization of “cyber devices.” The legislation gave the FDA the authority to refuse submissions that lack cybersecurity information.
  • The new draft section explains which devices are covered by the requirements, the documents affected companies should submit and how the FDA interprets the phrase “reasonable assurance of...

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Topics: Cybersecurity, FDA, Govt Agencies, Health IT, Medical Devices, Technology
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