HBV Surface Antigen Tests Required Under Proposed Tissue Reg
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers of human cellular and tissue-based products should use surface antigen tests for hepatitis B rather than core antibody HBV assays, FDA states in a Sept. 30 proposed rule.
You may also be interested in...
Tissue Regs On Horizon Despite Manufacturer Concerns
FDA should regulate threaded cortical bone dowels as a device, rather than a tissue, because it is indicated for a specific use, Stryker Biotech maintains in comments to the agency.
Tissue Regs On Horizon Despite Manufacturer Concerns
FDA should regulate threaded cortical bone dowels as a device, rather than a tissue, because it is indicated for a specific use, Stryker Biotech maintains in comments to the agency.
Tissue, Cell-Based Product Reg Needs Some Clarification - FDA Staffers
FDA's proposed rule to establish regulations on human cellular or tissue-based medical equipment requires further clarification, agency staffers acknowledged.