Sec. 3055. CLASSIFICATION PANELS
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## SEC. 3055 CLASSIFICATION PANELS ###
(a)Classification Panels Paragraph
(5)of section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended— ####
(1)by striking “(5)” and inserting “(5)(A)”; and ####
(2)by adding at the end the following: > > ##### “(B) > > When a device is specifically the subject of review by a classification panel, the Secretary shall— > > > ###### “(i) > > ensure that adequate expertise is represented on the classification panel to assess— > > > ###### “(I) > > the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose; and > > > ###### “(II) > > the technology of the device; and > > > ###### “(ii) > > provide an opportunity for the person whose device is specifically the subject of panel review to provide recommendations on the expertise needed among the voting members of the panel. > > > ##### “(C) > > For purposes of subparagraph (B)(i), the term ‘adequate expertise’ means that the membership of the classification panel includes— > > > ###### “(i) > > two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and > > > ###### “(ii) > > at least one voting member who is knowledgeable about the technology of the device. > > > ##### “(D) > > The Secretary shall provide an annual opportunity for patients, representatives of patients, and sponsors of medical device submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.” > . ###
(b)Panel Review Process Section 513(b)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended— ####
(1)in subparagraph (A)(iii), by inserting before the period at the end “, including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person’s organization to address such specific issues in the time provided”; and ####
(2)by striking subparagraph
(B)and inserting the following new subparagraph: > > ##### “(B) > > > ######
(i)> > Any meeting of a classification panel with respect to the review of a device shall— > > > ###### “(I) > > provide adequate time for initial presentations by the person whose device is specifically the subject of such review and by the Secretary; and > > > ###### “(II) > > encourage free and open participation by all interested persons. > > > ###### “(ii) > > Following the initial presentations described in clause (i), the panel may— > > > ###### “(I) > > pose questions to a designated representative described in subparagraph (A)(iii); and > > > ###### “(II) > > consider the responses to such questions in the panel’s review of the device.” > .
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Sec. 3055
CLASSIFICATION PANELS
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