Sec. 3059. Cleaning instructions and validation data requirement
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/bill/114/hr/34/enr/section-3059·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 510 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ) is amended by adding at the end the following: Not later than 180 days after the date of enactment of the 21st Century Cures Act , the Secretary shall identify and publish a list of reusable device types for which reports under subsection
(k)are required to include— instructions for use, which have been validated in a manner specified by the Secretary; and validation data, the types of which shall be specified by the Secretary; regarding cleaning, disinfection, and sterilization, and for which a substantial equivalence determination may be based. The Secretary shall revise the list under paragraph (2), as the Secretary determines appropriate, with notice in the Federal Register. Reports under subsection
(k)that are submitted after the publication of the list described in paragraph (1), for devices or types of devices included on such list, shall include such instructions for use and validation data. . The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) ) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject.
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Sec. 3059
Cleaning instructions and validation data requirement
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