§230.72. Change in ownership of a granted certification.
21 C.F.R. § 230.72
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:
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.
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.
Notes, amendments, and revision history
Authority
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.
Source
Source: 89 FR 51777, June 18, 2024, unless otherwise noted.