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FDA GMP Medical Device Laboratory needed for biocompatibility testing of polypropylene mesh for medical use for a 510(k) application in accordance with the Blue Book Guidance G95-1, (Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing), acceptable test results should be supplied for the biological tests listed below. Standard protocols such as those identified by the USP or ASTM should be used in conducting the biocompatibility testing, if possible. Such tests should be performed on devices ready for surgical use (i.e., after manufacture, sterilization and packaging for commercial distribution).
Irritation or Intracutaneous reactivity
Systemic toxicity (acute)
Implantation (with histology of the surrounding tissue)
For products that remain in the body for greater than 30 days, the following additional tests are recommended:
Long term carcinogenicity studies should be performed with any device in which a positive genotoxitiy test result was obtained.
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