Sec. 2225. Easing regulatory burden with respect to certain class I and class II devices
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Section 510(l) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(l) ) is amended— by striking A report under subsection
(k)and inserting
(1)A report under subsection
(k); and by adding at the end the following new paragraph: Not later than 120 days after the date of the enactment of the 21st Century Cures Act , 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— each type of class I device so identified shall be exempt from the requirement for a report under subsection (k); and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. . Section 510(m) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(m) ) is amended— by striking paragraph
(1)and inserting the following new paragraph: The Secretary shall— not later than 60 days after the date of the enactment of the 21st Century Cures Act — 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 provide for a period of not less than 60 days for public comment beginning on the date of the publication of such notice; and not later than 180 days after the date of the enactment of 21st Century Cures Act , publish in the Federal Register a list representing the Secretary’s final determination with respect to the devices included in the list published under subparagraph (A). ; in paragraph (2)— by striking 1 day after the date of the publication of a list under this subsection, and inserting 1 day after the date of publication of the final list under paragraph (1)(B), ; and by striking 30-day period and inserting 60-day period ; and by adding at the end the following new paragraph: Upon the publication of the final list under paragraph (1)(B)— each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. .
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Sec. 2225
Easing regulatory burden with respect to certain class I and class II devices
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