The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Administrative / Procedural, Premarket
Published
July 28, 2014
Last updated
March 28, 2019
Description
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and FDA Staff." A guidance document on evaluating substantial equivalence in premarket notifications.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)