FDA Revises cGMP and Labeling Regulations of Medical Gases

• By: Staff Editor
• Date: November 21, 2016
• Source: http://www.raps.org/

The US FDA recently amended its cGMP and labeling regulations for medical gases. The chief impetus for modifying the regulation was the number of injuries and deaths where medical gas containers carrying gases other than oxygen were falsely connected to a healthcare’s facility oxygen supply system.

FDA in the Federal Register said, “The final rule is intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container.”