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Sponsors can use eSubmitter to create change of sponsor name or address submissions and submit these electronically. If a sponsor owns an approved application that is affected by the change, they use either the N-C-AD or A-C-AD eSubmitter template to create their submission.
If you wish to assign a new correspondent who is not registered with the FDA, please visit the Accounts Management site. Select the facility you wish to change, and select the Change Official Correspondent option. To complete the transaction, click the box next to the Certification Statement and Submit.
1114.13 Change in ownership of an application. (a) The new and former owner must sign and submit a notice to FDA stating that all of the former applicants rights and responsibilities relating to the PMTA have been transferred to the new owner.
CDRH Portal, check the Portal Help articles inside the CDRH Portal, or email ccp@fda.hhs.gov.
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