CERTAIN CLASS I AND CLASS II DEVICES.

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.” .