adequate expertise
Defined in 1 place of the United States Code.
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.
Source
- 2016–present21 U.S.C. § 360CFood and Drugs · Classification of devices intended for human use · in this section