Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA Reviewers

Information

Type

Guidance

Regulated products

Medical Devices

Published

August 8, 2000

Last updated

March 18, 2020

Description

This document provides guidance for industry and FDA reviewers on Section 216 of the FDA Modernization Act of 1997.

Organization

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

Actions

Social networks

Embed