; and (2) laboratories using laboratory-developed testing procedures should adhere to personnel requirements required under section 353 of the Public Health Service Act ( 42 U.S.C. 263a ), including such requirements relating to qualified professionals who direct and supervise laboratories and consult on diagnosis, treatment, and management of patient care, and render opinions to clients concerning diagnosis, treatment, and management of patient care required under such section 353. (c) Authority over laboratory-Developed testing procedures All aspects of a laboratory-developed testing procedures shall be regulated by the Secretary of Health and Human Services under section 353 of the Public Health Service Act ( 42 U.S.C. 263a ), and no aspects of laboratory-developed testing procedures shall be regulated under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), including during a public health emergency declared under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ). (d) Definition In this section, the term laboratory-developed testing procedure means a professional medical service that utilizes a laboratory examination in the context of clinical care or public health services and that meets the standards for establishment of performance specifications established by regulation under section 353(f) of the Public Health Service Act ( 42 U.S.C. 263a(f) ) applicable to— (1) laboratory modifications of test systems approved, cleared, or authorized by the Food and Drug Administration under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) , 360c, 360e, 360bbb–3); (2) methods developed or performed, and results produced and interpreted, within a laboratory or laboratories under common ownership or within the same organization, certified as required under section 353(c) of the Public Health Service Act ( 42 U.S.C. 263a(c) ); (3) standardized methods such as those that are available in textbooks and peer-reviewed publications