INVESTIGATIONAL DEVICE EXEMPTIONS.

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.” .