00055 VALID Act- Well-Characterized
“(20) WELL-CHARACTERIZED.—The term ‘well-characterized’, with respect to an in vitro clinical test, means well-established and well-recognized by the scientific or clinical community, if adequately evidenced by one or more of the following:
“(A) Peer-reviewed literature.
“(B) Practice guidelines.
“(C) Consensus standards.
“(D) Recognized standards of care.
“(E) Technology in use for many years.
“(F) Scientific publication by multiple sites.
“(G) Adoption by the scientific or clinical community.
“(H) Real world data.
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