00052 VALID Act: Valid Scientific Evidence

00052 VALID Act: Valid Scientific Evidence

From VALID Act Definitions

“(19) VALID SCIENTIFIC EVIDENCE.—The term ‘valid scientific evidence’—

“(A) means, with respect to an in vitro clinical test, evidence—

“(i) that has been generated and evaluated by persons qualified by training or experience to do so, using procedures generally accepted by other persons so qualified; and

“(ii) from which it can be fairly and responsibly concluded by qualified experts whether the applicable standard has been met by the in vitro clinical test for its intended use; and

“(B) may include evidence described in subparagraph (A) consisting of—

“(i) peer-reviewed literature;

“(ii) clinical guidelines;

“(iii) reports of significant human experience with an in vitro clinical test;

“(iv) bench studies;

“(v) case studies or histories;

“(vi) clinical data;

“(vii) consensus standards;

“(viii) reference standards;

“(ix) data registries;

“(x) postmarket data;

“(xi) real world data;

“(xii) clinical trials; and

“(xiii) data collected in countries other than the United States if such data are demonstrated to be adequate for the purpose of making a regulatory determination under the applicable standard in the United States.