Sec. 517. Remote records assessments for medical devices
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Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(4)(A) ) is amended— in the first sentence, by inserting or device after processing of a drug ; and in the second sentence, by striking shall include and all that follows through the period at the end and inserting the following: “shall include— a description of the records requested; and a rationale for requesting such information in advance of, or in lieu of, an inspection. . Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance describing circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection, processes for responding to such requests electronically or in physical form, and factors the Secretary intends to consider in evaluating whether such records are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.
The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.
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Sec. 517
Remote records assessments for medical devices
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