Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
Medical Devices
Published
June 2, 2004
Last updated
February 28, 2020
Description
Guidance document on validation data for reprocessed single-use medical devices under the Medical Device User Fee and Modernization Act of 2002.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)