Maps to
21 CFR Part 822: §822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
Requirement text
When the sponsor of a postmarket surveillance plan or an investigator in the plan changes, the manufacturer must ensure that all records related to the postmarket surveillance are transferred to the new sponsor or investigator. FDA must be notified within 10 working days of the effective date of the change. The notification must provide the name, address, and telephone number of the new sponsor or investigator, certify that all records have been transferred, and provide the date of transfer.