By law, laboratories may not use "home- brew" or non- FDA approved tests.

Name: By law, laboratories may not use "home- brew" or non- FDA approved tests.
Brand: Quizplus
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Question

Quizplus · Accepted Answer

Laboratories in the United States can use "home-brew" tests (Laboratory Developed Tests, LDTs) under certain conditions without FDA approval, as these tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA) rather than by the FDA, although the FDA has the authority to regulate them if it chooses to do so.

By Law, Laboratories May Not Use "Home- Brew" or Non-