Maps to
21 CFR Part 822: §822.27 If I go out of business, what must I do?
Requirement text
A manufacturer subject to a postmarket surveillance order that decides to close its business must notify FDA within 30 days of that decision. The notification should provide the expected date of closure and should discuss plans for completing or terminating the postmarket surveillance. The manufacturer must also identify who will retain the surveillance records and where those records will be kept after closure.