FDA Releases Rules to Shield Medical Devices from Cyber Threats
Published Date: 6/27/2025
Notice
Summary
The FDA just dropped new rules to make medical devices safer from hackers. If you make or sell these devices, you’ll need to follow updated steps for design, labeling, and paperwork to prove your device is secure. These changes kick in soon and could affect how much time and money you spend getting devices approved.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
New FDA Cybersecurity Submission Guidance
The FDA issued a final guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" that updates the September 27, 2023 guidance and finalizes the March 13, 2024 draft. If you make or sell medical devices with cybersecurity risk, the guidance recommends what cybersecurity design, labeling, and documentation to include in premarket submissions and identifies information FDA considers necessary to meet obligations under the new amendments to the Federal Food, Drug, and Cosmetic Act (including Section 524B).
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