21 CFR 820.184 - Device History Record (QMSR)

What it says

A device history record must be maintained for each unit, lot or batch of a finished device, demonstrating the device was manufactured in accordance with the device master record, including dates of manufacture, quantity manufactured and released, and acceptance records demonstrating the device meets specifications.

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

What it means in practice

• The device history record is the device-side equivalent of the drug batch production record, serving the same fundamental purpose of demonstrating a specific unit or lot was manufactured according to its approved specifications.
• Acceptance records within the device history record must demonstrate actual conformance to specifications, not simply assert that specifications were met without supporting data.
• Traceability from the device history record back to the device master record is essential, since the device history record's whole purpose is demonstrating adherence to that master record for the specific unit or lot in question.

What FDA inspectors look for

• Whether device history records are complete and contemporaneous, with acceptance data genuinely supporting conformance claims rather than summary statements alone.
• Whether traceability between the device history record and the device master record is clear and demonstrable for the specific units reviewed.
• Whether gaps or inconsistencies in device history records are caught through internal review, rather than only being discovered during external inspection.

Related regulations