21 CFR 820.65 - Traceability

What it says

For devices where the device manufacturer determines that tracing a particular device or component is necessary to prevent recurrence of a problem that could result in significant health consequences, traceability must be established and maintained to identify the component, material and manufacturing history of individual units or lots.

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

What it means in practice

• This traceability requirement is targeted and risk-based, it applies where failure consequences are serious enough to justify the additional recordkeeping burden, not uniformly to every device and component a manufacturer handles.
• A device manufacturer's risk assessment of which components require this level of traceability is itself subject to scrutiny, since underestimating which failures carry significant health consequences undermines the entire traceability system's purpose.
• Traceability data built under this provision is what ultimately makes a targeted recall or field correction possible without having to act on an entire unaffected product line.

What FDA inspectors look for

• Whether the manufacturer's determination of which devices or components require traceability under this provision is documented and risk-based.
• Whether traceability records are complete enough to actually identify specific component and manufacturing history for an individual unit or lot, not just the device model generally.
• Whether a traceability system was tested or exercised, such as during a mock recall, to confirm it functions as intended.

Related regulations