Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Digital Health, Premarket
Published
September 27, 2023
Last updated
September 26, 2023
Description
Guidance document on premarket submissions for cybersecurity in medical devices, providing quality system considerations.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)