Party
Party means the center of the Food and Drug Administration responsible for a matter involved and every person who either has exercised a right to request or has been granted the right by the Commissioner to have a hearing under part 12 or part 16 or who has waived the right to a hearing to obtain the establishment of a Public Board of Inquiry under part 13 and as a result of whose action a hearing or a Public Board of Inquiry has been established.
Source
21 CFR § 10.3
Scoping language
The following definitions apply in this part and parts 12, 13, 14, 15, 16, and 19: