adequate expertise
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 360C — in this section
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.