21 CFR § 26.38
Other transition period activities
June 25, 2020
(a) During the transition period, the parties will jointly determine the necessary information which must be present in quality system and product evaluation reports.
(b) The parties will jointly develop a notification and alert system to be used in case of defects, recalls, and other problems concerning product quality that could necessitate additional actions (e.g., inspections by the parties of the importing country) or suspension of the distribution of the product.