Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer Guidance for Industry and for FDA Reviewers January 2000
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
The purpose of this document is to facilitate the preparation and the review of premarket submissions for nitric oxide delivery apparatus, nitric oxide analyzers, and nitrogen dioxide analyzers.
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-1999-D-4090.