Human Cells & Tissue Based Products

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This...

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harm...

The Food and Drug Administration (FDA, the Agency, or we) is proposing new regulations that would amend the requirements concerning current good manufacturing practice (CGMP) and postmarketing safety reporting that apply to certain medical gases. FDA...

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard f...

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electroni...

The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list h...

The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (ED...

The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-base...

The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak ca...

The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based p...

The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP...

The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cel...

The Food and Drug Administration (FDA) is issuing a final rule to require human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based product...

The Food and Drug Administration (FDA) is proposing new regulations to require manufacturers to follow current good tissue practice, which includes methods used in, and the facilities and controls used for, the manufacture of human cellular and tissu...