What Healthcare Cybersecurity Leaders Should Know About the FDA’s Section 524B Guidelines
November 20, 2023 at 06:26PM The FDA has issued updated regulations regarding the cybersecurity requirements for medical devices. The regulations, found in Section 524B of the FD&C Act, went into effect on October 1, 2023. They apply to anyone submitting a premarket application for a “cyber device.” The purpose of the regulations is to ensure … Read more