HR 2227 · 112th Congress · Health
Medical Gas Safety Act
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2011-06-22)
Plain Language Summary
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Medical Gas Safety Act - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions regarding the regulation of medical gases, including to establish a certification and approval process for medical gases. Lists designated medical gases, including oxygen, nitrous oxide, and medical air. Requires the Secretary to: (1) approve a certification for designated medical gases; and (2) establish by rule appropriate procedures for the approval of medical gases that are not designated medical gases. Requires the Secretary to establish regulations for medical gases, including: (1) appropriate current good manufacturing practice requirements, (2) separate labeling requirements, (3) separate wholesale distribution requirements, (4) a streamlined electronic process for registration and listing of medical gases, and (5) separate and proportionate product tracking and anti-counterfeiting rules for medical gases. Requires the Secretary to establish: (1) a separate risk-based inspection regime specific to medical gas manufacturers that ensures coordination with state and local inspection activities, and (2) the Medical Gas Advisory Committee to provide the Secretary with regular guidanc…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (10)
6 Democrats4 Republicans