§ 73a.735-502 Employees in regulatory activities.

(a) An employee in regulatory activities (“control activity” employee) may hold financial interests in an FDA-regulated organization only if either of the following conditions are met:

(1) The regulated activities of the organization are an “insignificant” part of its total business operations, or

(2) Written approval for an individual exception is granted by the Commissioner in accordance with § 73a.735–504; however, such approval will not be considered unless all of the following conditions are met: