If the medical device involves components that come into direct or indirect touch with tissue, the FDA requires that the biocompatibility of tissue-contacting materials be evaluated. Biocompatibility testing is carried out in accordance with ISO 10993-1.
Even though the subject device and the predicate device have the same material and construction, biocompatibility studies must be conducted to demonstrate the device’s biological safety.
The reviewer will require information on the testing process and reports in detail. The protocol must comprise the study title and standard, preparation of the test article, thorough test method-positive and negative controls, test parameters and acceptance criteria, and analysis of the results. The report must include an analysis of the test results, conclusions drawn from the data, a photograph of the gadget, and so on.