CLARIFICATION OF LEAST BURDENSOME STANDARD.

SEC. 602. CLARIFICATION OF LEAST BURDENSOME STANDARD. (a) Premarket Approval.—Section 513(a)(3)(D) (21 U.S.C. 360c(a)(3)(D)) is amended— (1) by redesignating clause (iii) as clause (v); and (2) by inserting after clause (ii) the following: “(iii) For purposes of clause (ii), the term ‘necessary’ means the minimum required information that would support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device. “(iv) Nothing in this subparagraph shall alter the criteria for evaluating an application for premarket approval of a device.” . (b) Premarket Notification Under Section 510(k).—Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended— (1) by striking “(D) Whenever” and inserting “(D)(i) Whenever”; and (2) by adding at the end the following: “(ii) For purposes of clause (i), the term ‘necessary’ means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device. “(iii) Nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device.” .