(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.

(b) With respect to a regulatory hearing required by the act or a regulation under §16.1(b)—

(1) The administrative record of the hearing specified in §16.80(a) constitutes the exclusive record for decision;

(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) 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.