Home / Agencies / FDA / 2024-21684
Proposed Rule

DSM Biomedical; Filing of Color Additive Petition

Agency
FDA
Document Number
2024-21684
Published
September 23, 2024
Effective Date
-

Abstract

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of phthalocyanine green to color surgical sutures made of ultra- high molecular weight polyethylene (UHMWPE) for use in general surgery, at a concentration of no more than 0.5 percent by weight of the suture.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

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Frequently Asked Questions

What is the 2024-21684 Federal Register document?
Document 2024-21684 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on September 23, 2024. The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of phthalocyanine green to color surgical sutures made of ultra- high molecular weight polyethylene (UHMWPE) for use in general surgery, at a concentration of no more than 0.5 percent by weight of the suture. View the original at https://www.federalregister.gov/documents/2024/09/23/2024-21684/dsm-biomedical-filing-of-color-additive-petition.
Is document 2024-21684 an economically significant rule?
No. Document 2024-21684 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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