Sec. 3054. CERTAIN CLASS I AND CLASS II DEVICES
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## SEC. 3054 CERTAIN CLASS I AND CLASS II DEVICES ###
(a)Class I Devices Section 510(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended— ####
(1)by striking “A report under subsection (k)” and inserting “(1) A report under subsection (k)”; and ####
(2)by adding at the end the following new paragraph: > > #### “(2) > > Not later than 120 calendar 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, the Secretary shall identify, through publication in the Federal Register, any type of class I device that the Secretary determines no longer requires a report under subsection
(k)to provide reasonable assurance of safety and effectiveness. Upon such publication— > > > ##### “(A) > > each type of class I device so identified 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.” > . ###
(b)Class II Devices Section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended— ####
(1)by striking “ (m)(1) ” and all that follows through “ by the Secretary. ” and inserting the following: > > ### “(m) > > > ####
(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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Sec. 3054
CERTAIN CLASS I AND CLASS II DEVICES
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