Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Premarket
Published
June 18, 2007
Last updated
March 19, 2020
Description
This is a guidance document by the FDA for pre-clinical and clinical studies on neurothrombectomy devices, focusing on GCP and premarket requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)