Sec. 2226. Advisory committee process
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Paragraph
(5)of section 513(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(b) ) is amended— by striking
(5)and inserting (5)(A) ; and by adding at the end the following: When a device is specifically the subject of review by a classification panel, the Secretary shall— ensure that adequate expertise is represented on the classification panel to assess— the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose; and the technology of the device; and as part of the process to ensure adequate expertise under clause (i), give due consideration to the recommendations of the person whose premarket submission is subject to panel review on the expertise needed among the voting members of the panel. For review by a classification panel of a premarket submission for a device, the Secretary shall— provide an opportunity for the person whose premarket submission is subject to panel review to provide recommendations on the expertise needed among the voting members of the panel; and give due consideration to such recommendations and ensure that adequate expertise is represented on advisory panels to assess— the disease or condition for which the device is intended to cure, treat, mitigate, prevent, or diagnose; and the technology of the device. For purposes of subparagraph (B)(ii), the term adequate expertise means, with respect to the membership of the classification panel reviewing a premarket submission, that such membership includes— two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and at least one voting member who is knowledgeable about the technology of the device. . Section 513(b)(6) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(b)(6) ) is amended— in subparagraph (A)(iii), by inserting before the period at the end , including by designating a representative who will be provided a time during the panel meeting to address the panel individually (or accompanied by experts selected by such representative) for the purpose of correcting misstatements of fact or providing clarifying information, subject to the discretion of the panel chairperson ; and by striking subparagraph
(B)and inserting the following new subparagraph: Any meeting of a classification panel for a device that is specifically the subject of review shall— provide adequate time for initial presentations by the person whose device is specifically the subject of a classification panel review and by the Secretary; and encourage free and open participation by all interested persons. Following the initial presentations described in clause (i), the panel may— pose questions to a designated representative described in subparagraph (A)(iii); and consider the responses to such questions in the panel’s review of the device that is specifically the subject of review by the panel. .
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Sec. 2226
Advisory committee process
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