21 C.F.R. § 230.72

Current through November 30, 2024

Section 230.72 - [Effective 12/18/2025] Change in ownership of a granted certification

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.

21 C.F.R. §230.72

89 FR 51777 , 12/18/2025