Recently released relevant guidance, 2023-2024

Note on this topic: For the full spectrum of FDA Guidance Documents pertaining to medical devices, including Software as a Medical Device, browse or search documents available on the FDA website here. Note that the FDA center responsible for medical device regulation is the Center for Devices and Radiological Health, CDRH, website here.

• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" (Link)

• Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology (Link)

• Requests for Feedback and Meetings for Medical Device Submissions: the Q-Submissions Program (Link)

• Content of Premarket Submissions for Device Software Functions (Link)

• Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Link)