Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Clinical - Medical, Combination Products, Digital Health, Premarket
Published
September 29, 2023
Last updated
October 6, 2023
Description
This document provides guidance for the industry and FDA staff on technical considerations for medical devices with closed-loop control technology.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)