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We are an IVD medical device manufacturer and as part of the acceptance testing of our product we subject it to a variety of analytical tests. The tests we conduct on our product are done with another manufacturer's 510k cleared reagents, but we do not exactly follow the manufacturer's directions for use. The main reason we do not follow their directions is that we are using a different analyzer than indicated in their directions. I was looking for a requirement for method validation for this circumstance in 21CFR820 but can't find any. So my question is, is there a regulatory requirement for test method validation for tests that are used as part of acceptance testing, and if so which section of 21CFR820 is this referenced in. Also, if anyone can point me to some good method validation guideance documents that would be greatly appreciated.
Thank you
Thank you