A person who wishes to be accredited by FDA to conduct establishment inspections: - may not be an employee of the Federal Government;
- may not be owned by, or have an “affiliation (including a consultative affiliation)” with a device manufacturer, supplier, or vendor;
- cannot be engaged in the design, manufacture, promotion, or sale of FDA-regulated products;
- must operate “in accordance with generally accepted professional and ethical business practices” and must agree in writing to certain fundamental operating principles;
- may not have a financial conflict of interest regarding any FDA-regulated product.
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