Maps to
21 CFR Part 822: §822.26 If my company changes ownership, what must I do?
Requirement text
When a company subject to a postmarket surveillance order undergoes a change in ownership, the manufacturer must notify FDA within 30 days of the change. The notification should identify any changes to the company's name or address, the contact person, or the designated person as defined in §822.3(b). The obligation to conduct postmarket surveillance generally transfers to the new owner; however, if both parties agree that the original manufacturer will continue the surveillance, that arrangement is permissible — but the original manufacturer must still notify FDA of the ownership change.