CBBS: Does Biologic Product Deviation Reporting for HCT/Ps include non-human source tissue, such as skin grafts?
On November 24, 2004, the Food and Drug Administration published a final rule that includes requirements in 21 CFR Part 1271.350(b) for reporting certain deviations in manufacturing of Human Cells, Tissues, and Cellular and Tissue-Based Products. A physician in Los Angeles asks if colleagues are aware if this rule requires reporting a Biologic Product Deviation (BPD) for errors, accidents or incidents involving the dispensing non-human source tissue (such as 'skin grafts'). For example, if a product such as Integra™ Bilayer Matrix Wound Dressing were to be dispensed by a laboratory in a fashion that jeopardized the safety, potency, or purity of that product, would a BPD need to be reported?
ADDENDA Feb 8, 2005
The following comments have been received.
- Sharon O'Callaghan, Program Surveillance Branch, DIS/OCBQ/CBER/FDA (attribution used with permission) reports that non-human source tissue, such as skin grafts is generally regulated as a medical device at CDRH. These products would be subject to the applicable device reporting requirements. The HCT/P Deviation (BPD) reporting does not apply to non-human tissue products.
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