00063 Manual Test Exemption
“(f) Manual tests.—
“(1) EXEMPTION.—An in vitro clinical test is exempt from all requirements of this subchapter if the output of such in vitro clinical test is the result of direct, manual observation, without the use of automated instrumentation or software for intermediate or final interpretation, by a qualified laboratory professional, and such in vitro clinical test—
“(A) is designed, manufactured, and used within a single clinical laboratory for which a certificate is in effect under section 353 of the Public Health Service Act that meets the requirements under section 353 for performing high-complexity testing;
“(B) is not a high-risk test, or is a high-risk test that the Secretary has determined meets at least one condition in paragraph (2) and is otherwise appropriate for this exemption; and
“(C) is not intended for testing donors, donations, and recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products.
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