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  1. Economic Impact Analyses of FDA Regulations

Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases (Final Rule)

This final rule establishes, within 21 Code of Federal Regulations (CFR) Part 213, current good manufacturing practice (CGMP) regulations specific to medical gases. These regulations include many of the same categories of requirements as the general drug product CGMP regulations but are tailored to reflect differences in how medical gases are manufactured, packaged, labeled, stored, and distributed. 

This rule makes limited changes to the labeling requirements of part 201 including requiring that a “no smoking” statement, a “no vaping” statement, and graphic warning symbol be added to oxygen containers to reduce the risk of fire. This rule codifies and clarifies the process for obtaining a certification to market designated medical gases (DMGs). Recommendations for how to request a certification for DMGs are currently included in a draft guidance. This rule makes changes to postmarketing safety reporting regulations for DMGs that address human and animal use and more specifically reflect the development, manufacturing, and distribution of DMGs.

The annualized benefits will range from $0.00 million to $7.02 million with a primary estimate of $3.51 million over a 10-year span at a 7 percent discount rate. Annualized at a 3 percent discount rate these benefits will range from $0.00 million to $7.43 million with a primary estimate of $3.72 million. The annualized costs will range from $1.52 million to $5.30 million with a primary estimate of $3.24 million at a 7 percent discount rate. Annualized at a 3 percent discount rate these costs will range from $1.36 million to $5.11 million with a primary estimate of $3.07 million.

Regulatory Impact Analysis

Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases (Final Rule) (PDF 628KB)

Federal Register: 89 FR 51738
Publication Date: 6/18/2024 
Docket: FDA-2021-N-1333

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