Which characteristic is true for an FDA-approved test?

An FDA-approved test must have the manufacturer demonstrate its claimed effectiveness as part of the approval process. This means that the manufacturer is required to provide scientific evidence that supports the accuracy, reliability, and clinical relevance of the test. This rigorous evaluation process helps ensure that the test will perform as intended when used in a clinical setting, thereby safeguarding public health by ensuring that diagnostic tests provide accurate and reliable results for patients.

In contrast, while extensive clinical trials may be a part of the process, they are not universally required for all FDA approvals, particularly for some lower-risk devices. Marketing a test without FDA involvement is generally not permissible for tests requiring FDA approval, as the FDA's oversight is essential for ensuring safety and efficacy. Lastly, the cost of producing a test does not factor into its FDA approval status, as tests can vary widely in production costs regardless of their approval status. Thus, the requirement for manufacturers to demonstrate effectiveness is a fundamental aspect of the FDA approval process.