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1)The Secretary shall- (A)not later than 90 days after the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as the Secretary determines appropriate- (i)publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness; and (ii)provide for a period of not less than 60 calendar days for public comment beginning on the date of the publication of such notice; and (B)not later than 210 calendar days after the date of enactment of the 21st Century Cures Act, publish in the Federal Register a list representing the Secretary’s final determination with respect to the devices contained in the list published under subparagraph (A).; and (2)in paragraph (2)- (A)by striking 1 day after the date of publication of a list under this subsection, and inserting 1 calendar day after the date of publication of the final list under paragraph (1)(B),; and (B)by striking 30-day period and inserting 60-calendar-day period; and (C)by adding at the end the following new paragraph: (3)Upon the publication of the final list under paragraph (1)(B)- (A)each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and (B)the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption..



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