; or (ii) to mitigate the risk of harm ensuing from an undetected inaccurate result or misinterpretation of a result; and (B) may include, as required by the Secretary, as appropriate, applicable requirements regarding labeling, conformance to performance standards and consensus standards, performance testing, submission of clinical data, advertising, website posting of information, clinical studies, postmarket surveillance, user comprehension studies, training, and confirmatory laboratory, clinical findings, the history of the developer, the role of a health professional in the testing process, such as integration of the testing laboratory into the direct medical care of the patient, including direct interaction between the testing laboratory and treating physician, or testing. (16) Moderate-risk The term moderate-risk , with respect to an in vitro clinical test or category of in vitro clinical tests— (A) means a test or category of tests that is not high-risk under the criteria under paragraph (9) or low-risk under the criteria under paragraph (14); and (B) may include a test or category of tests that, when used as intended, meet the criteria specified in paragraph (9)(A) for high-risk, but for which one or more mitigating measures are able to be established and applied to prevent, mitigate, or detect an inaccurate result or otherwise sufficiently mitigate the risk resulting from an undetected inaccurate result, but are not sufficient such that the test is low-risk under the criteria in paragraph (14). (17) Specimen receptacle The term specimen receptacle means an in vitro clinical test intended for taking, collecting, holding, storing, or transporting of specimens derived from the human body or for preparation, analysis, or in vitro clinical examination for purposes described in section 201(ss)(1). (18) Technology The term technology — (A) means a set of control mechanisms, energy sources, or operating principles— (i) that do not differ significantly among multiple in vitro clinical tests