Revocation of the Human Tissue Intended for Transplantation Regulations and Human Dura Mater (Final Rule) Regulatory Impact Analysis

FDA proposes to remove the regulations under part 1270 (21 CFR part 1270), “Human Tissue Intended for Transplantation” and § 882.5975 (21 CFR 882.5975), “Human dura mater.” These regulations apply to certain tissues recovered prior to May 25, 2005. The Agency does not believe there are currently any tissues intended for transplantation remaining in inventory that were recovered prior to this date and that would be subject to these regulations.

This Final Regulatory Impact Analysis discusses the economic impacts of the final rule, including potential costs, cost savings, and benefits. Because this rule would not impose any additional burden on the industry, this regulation is not anticipated to result in any compliance costs. The costs and cost savings to FDA resulting from removing an obsolete regulation are expected to be minimal.

Regulatory Impact Analysis

Revocation of the Human Tissue Intended for Transplantation Regulations and Human Dura Mater (Final Rule) Regulatory Impact Analysis - (PDF- 212KB)

Federal Register: 87 FR 2045, January 13, 2022

Docket: FDA-2020-N-1519