According to Kim Trautman, the FDA's expert on current good manufacturing practices for medical devices, poor supplier performance continues to drive a significant number of product recalls. The FDA's Quality System Regulation, 21 CFR, Part 820 delineates the requirements for supplier controls under §820.50 Purchasing Controls. The regulation allows for a significant amount of latitude in regards to compliance; however, quality compliance issues associated with a failure to comply with §820.50 continue to be frequently cited in FDA Form 483 observations and warning letters. 

Device manufacturers are required to evaluate and select their suppliers based on the supplier's ability to meet specified requirements, including quality and regulatory. It is imperative that the appropriate tools be available to facilitate an effective approach to supplier controls. The costs associated with establishing an effective approach to supplier controls should be considered part of the admission price to play in the FDA's sandbox.