Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 14, 2018
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Premarket, Administrative / Procedural
Status: Final

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff

The Food and Drug Administration (FDA) developed this document to provide guidance to industry and FDA staff about the appropriate use of national and international voluntary consensus standards (referred to as consensus standards) in the preparation and evaluation of premarket submissions for medical devices.

Download the Guidance Document