21 CFR 820.50 - Purchasing Controls (QMSR)

What it says

Manufacturers must establish procedures to evaluate and select suppliers, contractors and consultants based on their ability to meet specified requirements, defining the type and extent of control needed based on the evaluation results, and maintaining records of acceptable suppliers.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This is the device-side equivalent of drug supplier qualification under 211.84, applying a similar principle: the depth of ongoing control and monitoring should scale with documented supplier risk and performance, not be applied uniformly regardless of supplier history.
• Purchasing data, specifications, quality requirements and applicable device master record information, must be communicated clearly to suppliers, since a supplier cannot be held accountable to requirements it was never actually given.
• An approved supplier list functions as a controlled record under this provision, similar in principle to its drug-side equivalent, requiring the same discipline in keeping it current and QA-controlled.

What FDA inspectors look for

• Whether supplier evaluation and selection is documented with a clear rationale connecting the level of ongoing control applied to the supplier's actual demonstrated risk and performance.
• Whether purchasing documents clearly and completely communicate applicable specifications and quality requirements to suppliers.
• Whether the approved supplier list is maintained as a current, QA-controlled record reflecting actual supplier qualification status.

Related regulations