Sec. 602. CLARIFICATION OF LEAST BURDENSOME STANDARD
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## 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.” > .
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Sec. 602
CLARIFICATION OF LEAST BURDENSOME STANDARD
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