Distribution Records
QMSR distribution record requirements
Under 21 CFR Part 820 (QMSR), manufacturers must maintain distribution records for each type of device distributed. Distribution records must include:
- The name and address of the initial consignee
- The identification and quantity of devices shipped
- The date shipped
- Any control number(s) (lot, batch, or serial) used
Retention period
Distribution records must be retained for:
- A period equivalent to the design and expected life of the device, but not less than 2 years from the date of release for commercial distribution by the manufacturer
Device tracking
For certain high-risk devices, FDA may order device tracking under 21 CFR Part 821, requiring manufacturers to track devices through the distribution chain to the patient level. Tracking is ordered for devices where rapid identification of patients is critical for post-market safety actions.
UDI and distribution records
The UDI system (21 CFR Part 830) integrates with distribution records — the Device Identifier (DI) and Production Identifier (PI) on the device label enable traceability through the supply chain and support efficient recalls.