21 CFR §16.95

1. (a)With respect to a regulatory hearing at the Commissioner's initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form.
2. (b)With respect to a regulatory hearing required by the act or a regulation under § 16.1(b)—
   1. (1)The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision;
   2. (2)On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and
   3. (3)For purposes of judicial review under § 10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision.