Standard

CGA/GAS M-21

Published

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Abstract

This publication provides guidance for postmarketing quality and safety reporting (pharmacovigilance) to U.S. Food and Drug Administration (FDA) and Health Canada (HC). This guidance is intended to aid U.S. and Canadian companies that market common medical gases (i.e., oxygen, nitrogen, medical air, carbon dioxide, nitrous oxide, helium, and carbon monoxide and medically appropriate mixtures thereof) in setting up a pharmacovigilance reporting system that satisfies local and regional regulatory requirements, bearing in mind any global requirements when applicable. Common medical gases in the United States are referred to as designated medical gases or medically appropriate mixtures thereof. This publication does not address reporting requirements for gases or medical gas equipment classified as medical devices (materiovigilance). Nor does it address reporting requirements for medical gases approved under 21 CFR Part 314 [3].

Document information

  • Standard from CGA/GAS_AC
  • Published:
  • Version: 0
  • Document type: IS
  • Additional information
    • THIRD EDITION