Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices, Radiation-Emitting Products
Topics
Premarket
Published
June 16, 2022
Last updated
June 15, 2022
Description
This document is a guidance document titled "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions". It focuses on premarket topics and is intended for industry and FDA staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)