Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices Guidance for Industry and Food and Drug Administration Staff September 2018
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-0456.