Senior Regulatory Counsel

0910-AH96 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Updated Regulations for Medical Gases

FDA intends to propose revisions to certain regulations with regard to medical gases. These proposed changes are anticipated to include, but are not necessarily limited to, specific changes to current good manufacturing practice (cGMP), labeling, and postmarket reporting regulations applicable to medical gases, generally aiming for less stringent regulation where appropriate.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No Other Not Yet Determined Pub. L 115-31, sec. 756 (2017 Consolidated Appropriations Act) Statutory Final 07/15/2017 Statute enacted in May 2017 with July 2017 final rule deadline Section 756 of the 2017 Consolidated Appropriations Act (Pub. L. 115-31) directs FDA to issue final regulations revising the Federal drug regulations with respect to medical gases by July 2017. No NPRM 04/00/2019 Undetermined Undetermined Undetermined Undetermined No No David Faranda Senior Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-8767 david.faranda@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring MD 20993