Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater
Information
Type
Proposed Rule
Regulated products
Published
December 21, 2020
Last updated
December 21, 2020
Description
Document number 2020-27828. The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The proposed revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. FDA is proposing this action because these regulations are obsolete or no longer necessary to achieve public health goals. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive Orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)