Publication Detail: PS-54
CGA Position Statement on FDA Establishment Registration and Listing for Mixtures of Designated Medical Gases
Edition: 1
Published: February, 2018
Status: Available
Type: Position Statement
Catalog group: Position Statements
Size: 2 pages

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Publisher: CGA
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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.

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