NACDS Module 1 Exam Review 2024/2025

NACDS Module 1 Exam Review 2024/2025 A test that has been approved by the FDA, based on the manufacturer's data showing that it is safe and effective for its intended use. For a new type of test, or for a test that presents higher risk to the patient, the manufacturer performs studies to show that the test does what it claims to do and does not present any unreasonable risk. - ANS-Approved Test Uses methodologies that are so simple and accurate that the likelihood of erroneous results is negligible. Poses no reasonable risk of harm to the patient if the test is performed incorrectly. Is cleared by the FDA for home use. - ANS-CLIA-waived tests A test that has been cleared by the FDA, based on the manufacturer's data showing that it is similar to other tests that are already being sold. For a test that is similar to others already on the market and that is considered to have low risk to the user, manufacturers submit information to show that the test performs similarly to the other tests. The manufacturer submits the results in a "premarket notification" that the FDA reviews. If the FDA determines that the test is substantially equivalent to another test, the manufacturer can begin selling the test. - ANS-