Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Clinical - Medical, Good Clinical Practice (GCP), Labeling, Premarket
Published
March 9, 2020
Last updated
March 9, 2020
Description
This is a guidance document for the premarket notification of electrosurgical devices for general surgery, aimed at industry and FDA staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)