U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Digital Health Center of Excellence
  4. Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
  1. Digital Health Center of Excellence

Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)

This page provides answers to frequently asked questions (FAQs) related to cybersecurity in medical devices.

On December 29, 2022, the Consolidated Appropriations Act, 2023 ("Omnibus") was signed into law. Section 3305 of the Omnibus -- "Ensuring Cybersecurity of Medical Devices" -- amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices (section 3305). As provided by the Omnibus, the requirements of section 524B do not apply to an application or submission submitted to the Food and Drug Administration (FDA) before March 29, 2023. For devices submitted after March 29, 2023, the FDA generally intends not to issue "refuse to accept" (RTA) decisions for premarket submissions for cyber devices that are submitted before October 1, 2023, based solely on information required by section 524B of the FD&C Act. Instead, the FDA will work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process. The information provided on this page may be useful for sponsors in preparing their submissions.

Back to Top