![]() Test method developers should determine the risk associated with the test method by evaluating the severity of potential harm and the probability that the harm occurs. The level of validation should be commensurate with the risk associated with the test method being wrong. For example, a test for conformity of appearance may not require the same level of validation activities as a durability test replicating the clinical usage of the device. The extent of validation activities required for a given method is driven by its intended purpose and closely related to the risk of patient harm. ISO 17025 states: The validation shall be as extensive as is necessary to meet the needs of the given application or field of application. When establishing test method validation activities, first consider the purpose and risk associated with the test. A validated method provides confidence that the method is appropriate and that the data generated are reliable and repeatable. Test method validation gives an overall understanding of uncertainty of the method. ![]() Method validation is a documented process that is used to confirm that the procedure to be employed for a specific test is suitable for its intended purpose. Thus, to satisfy FDA expectations and avoid the pitfalls of using an inadequate test method, test methods used to produce data in support of regulatory filings or the manufacture of medical devices for human use need to be validated.ΔΆ1 CFR 820.3 states: Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Test methods that have not been validated yield a risk of the method being inadequate for evaluating medical devices and can lead to failed clinical devices, market recall and patient harm. Despite the lack of requirements, the FDA does have expectations around test method validation and has issued 483s and warning letters for insufficient method validation activities. The medical device industry has long understood the requirements related to process and software validation, however, US FDA Title 21 Code of Federal Regulations Part 820 Quality System Regulations does not have explicit requirements related to test method validation.
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