§812.46. Monitoring investigations. — Inbound Citations

(iv) Complies with the requirements of § 812.46 with respect to monitoring investigations;

(1) A sponsor who conducts an evaluation of an unanticipated adverse device effect under § 812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRB's and participating investigators within 10 working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA requests.