Biomedical Engineering Reference
In-Depth Information
material in that function is unknown. In general, the
FDA expects certain risks to be mitigated through
benchtop testing, animal testing, and clinical data
prior to marketing approval. These risks are likely not
specific to PEEK, but material-specific risks include
the risk of excessivewear debris generation, the risk of
device fracture/failure, and the risk of negative bio-
logic reaction to any device material or by-product.
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and abbreviated 510(k)s. Available from:
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andGuidance/GuidanceDocuments/ucm084365.
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, August 2005.
[8] Food and Drug Administration, Master files.
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[9] ASTM International, F2026-10 standard speci-
fication for polyetheretherketone (PEEK) poly-
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