§810.16. Cease distribution and notification or mandatory recall order status reports. — Inbound Citations

(3) Require the person named in the order to submit to the agency a proposed recall strategy, as described in § 810.14, and periodic reports describing the progress of the mandatory recall, as described in § 810.16; and

(a) The person named in a cease distribution and notification order issued under § 810.10 or a mandatory recall order issued under § 810.13 may request termination of the order by submitting a written request to FDA. The person submitting a request shall certify that he or she has complied in full with all of the requirements of the order and shall include a copy of the most current status report submitted to the agency under § 810.16. A request for termination of a recall order shall include a description of the disposition of the recalled device.