Pub. L. 105-115, tit. I, sec. 217
CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL.
SEC. 217. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL. Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking “clinical investigations” and inserting “1 or more clinical investigations”.