adequate expertise

(5) (A) Classification panels covering each type of device shall be scheduled to meet at such times as may be appropriate for the Secretary to meet applicable statutory deadlines. (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 devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.


21 USC § 360c(b)(5)

Scoping language

None identified, default scope is assumed to be the parent (part A) of this section.
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