Are there effective controls to prevent possible conflicts of interest in the third-party inspection program?
MDUFMA includes very stringent provisions designed to avoid conflict of interests. As described above, an accredited person may not be owned by, or have an affiliation with a device manufacturer, supplier, or vendor; cannot serve as a consultant; cannot be engaged in the design, manufacture, promotion, or sale of FDA-regulated products; and cannot have a financial interest in any FDA-regulated product. The new law requires FDA to audit the performance of third-party inspectors and to review the compliance history of each establishment whenever it requests a third-party inspection. There are also severe penalties if an accredited person violates the law, including permanent debarment, civil money penalties, and criminal prosecution. The law requires FDA to clear an establishment’s choice of an accredited person whenever it wishes to obtain a third-party inspection. The law permits FDA to ask for additional information concerning the establishment’s relationship with the third-party. And
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