Navigating Section 524B

As medical technology and medical devices have advanced with new technology and increasing connectivity, so have the threats to their cybersecurity. These threats endanger patient health, lives, and privacy. Cybersecurity is a major concern, and the U.S. government moved to address it by passing a December 2022 bill that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding Section 524B. This gave the Food and Drug Administration (FDA) statutory authority and a mandate around cybersecurity.

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