Sec. 601. INVESTIGATIONAL DEVICE EXEMPTIONS
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## SEC. 601 INVESTIGATIONAL DEVICE EXEMPTIONS Section 520(g) (21 U.S.C. 360j(g)) is amended— ####
(1)in paragraph (2)(B)(ii), by inserting “safety or effectiveness” before “data obtained”; and ####
(2)in paragraph (4), by adding at the end the following: > > ##### “(C) > > Consistent with paragraph (1), the Secretary shall not disapprove an application under this subsection because the Secretary determines that— > > > ###### “(i) > > the investigation may not support a substantial equivalence or de novo classification determination or approval of the device; > > > ###### “(ii) > > the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or > > > ###### “(iii) > > an additional or different investigation may be necessary to support clearance or approval of the device.” > .
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Sec. 601
INVESTIGATIONAL DEVICE EXEMPTIONS
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