; or (ii) affects the analytical or clinical validity of the in vitro clinical test as intended by the developer; or (D) adopting, using, or disseminating for use as an in vitro clinical test an article not previously intended for clinical use. (7) Developer The term developer means a person who engages in an activity described in paragraph (6) for clinical use. (8) First of a kind The term first-of-a-kind means, with respect to an in vitro clinical test, a test that has an intended use and a combination of the elements specified in paragraph (10) that differ from the intended use and such elements of other in vitro clinical tests that already are legally available in the United States. (9) High-risk (A) In general Subject to subparagraph (B), the term high-risk , with respect to an in vitro clinical test or category of in vitro clinical tests, means that an undetected inaccurate result from such test or category— (i) presents potential unreasonable risk for serious or irreversible harm or death to a patient or patients, or would otherwise cause serious harm to the public health; or (ii) is potentially likely to result in the absence, delay, or discontinuation of life-supporting or life-sustaining medical treatment. (B) Exception The term high-risk does not include an in vitro clinical test described in subparagraph (A) if mitigating measures are established and applied to sufficiently mitigate the risk of inaccurate results as described in subparagraph (A), including— (i) the degree to which the technology for the intended use of the in vitro clinical test is well-characterized, and the criteria for performance of the test are well-established to be sufficient for the intended use