martes, 17 de abril de 2018

FDA Public Workshop on Medical Gas Regulation- May 11, 2018

The Food and Drug Administration (FDA) will hold a public workshop on medical gas regulation, “Medical Gas Regulation: Workshop III” on May 11, 2018.  There is no cost and participants may attend in person or via live webcast. 

The purpose of the public workshop is to hear stakeholder views on areas FDA should consider for potential revisions to Federal drug regulation with respect to medical gases. During the workshop, FDA panels will discuss issues related to medical gas regulation, including topics previously raised at past public workshops. Potential areas for medical gas regulation change that stakeholders may wish to discuss include:  
  • Labeling
  • Current good manufacturing practice
  • Registration and listing
  • Post market reporting of adverse drug experiences
  • The designated medical gas certification process
  • Oxygen container filling by EMS providers and health care facilities
  • Other topics of interest to stakeholders or FDA
FDA has issued a Federal Register Notice and opened a public docket for written comments. Please see the Federal Register notice for more information about attending the public workshop or submitting comments to the public docket (due by August 9, 2018).  

For more information about this and previous workshops, please visit the Medical Gas Regulation Public Workshops page  or e-mail

Thank you for your interest in this and other topics related to FDA.

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