FDA Issues Final Rule for Medical Gasses
Published: 06/19/2024
Sources:
- Food and Drug Administration
Relevant To:
- Ambulatory Surgical Centers,
- Critical Access Hospitals,
- Hospitals,
- Long Term Care
The U.S. Food and Drug Administration (FDA) has published a final rule that establishes certification regulations for certain medical gases and amends the requirements for current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling.
The FDA engaged with stakeholders and Congress for several years to gather input and evaluate the need for regulatory changes within the medical gas industry. This rule clarifies the regulatory obligations of entities that manufacture…
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