CGA Position Statement on FDA Establishment Registration and Listing for Mixtures of Designated Medical Gases

Published by	Publication Date	Number of Pages
CGA	02/01/2018	2

Category: CGA

Description

CGA PS-54 – CGA Position Statement on FDA Establishment Registration and Listing for Mixtures of Designated Medical Gases

The U.S. Food and Drug Administration (FDA) drug registration and listing regulations, Title 21 of the U.S. Code of Federal Regulations (21 CFR) Part 207, do not address the unique properties of designated medical gas mixtures. Certain accommodations as presented in this position are made to conform with FDA?s requirements for electronic registration and listing submissions.