Certification Process for Designated Medical Gases; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Certification Process for Designated Medical Gases.'' The original version of this draft guidance was published by FDA on December 18, 2012. The revised draft guidance, like the original version, describes the certification process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical gases and explains how FDA plans to implement that process. In response to comments received, we have revised the draft guidance and are reissuing it in draft form to enable the public to review and comment before it is finalized.