Regulation Text
An applicant may transfer ownership of its certification. At the time of transfer the new and former owners are required to submit information to FDA as follows:
(a) The former owner must submit a letter or other document that states that all rights to the certification have been transferred to the new owner.
(b) The new owner must submit a supplement under § 230.70 signed by the new owner describing any changes in the conditions in the granted certification and a letter or other document containing the date that the change in ownership is effective.
Authority
21 U.S.C. 321,331,351,352,353,355,355a,355f,356,356a,356b,356c,356e,360b,360cc,360ddd,360ddd-1,371,374,379e,379k-1,381.