21 CFR Part 821 – Medical Device Tracking Requirements

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / QSR • Post-Market Traceability

21 CFR Part 821 establishes mandatory device tracking requirements for certain medical devices that must be traceable from manufacture to the patient or end user. These include life-sustaining, life-supporting, or permanently implantable devices, and others designated by FDA. The rule enables rapid corrective action and patient notification when safety issues arise.

“Part 821 extends GMP beyond the factory — enforcing cradle-to-patient accountability for high-risk medical devices.”

1) What It Is

Under Part 821, manufacturers must implement a formal tracking system capable of identifying the location, status, and recipients of specified devices. FDA may order additional tracking for products that pose significant public-health risks if not properly traced.

Scope & application. Applies to devices FDA designates for tracking — typically implantables, life-sustaining, and life-supporting products. Manufacturers, importers, and distributors must all participate in the tracking chain.

Selected requirements under Part 821:

• 821.20 Tracking orders. FDA may issue written orders requiring tracking for specified devices.
• 821.25 Information required. Manufacturers must capture device identifiers, lot/serial numbers, consignee data, and patient information where applicable.
• 821.30 Distributor obligations. Distributors must report sales and transfers within 10 days and maintain traceability records.
• 821.50 Record retention. Tracking records must be retained for the expected device life but not less than 2 years from final disposition.
• 821.60 Availability for inspection. All records must be readily accessible to FDA for audit and recall verification.

Relation to other rules. Works alongside Part 820 (QSR/CAPA), Part 803 (MDR), and Part 806 (Corrections & Removals) to create a closed loop of traceability and accountability.

2) FAQ

Q1. Which devices require tracking?
FDA-designated life-supporting, life-sustaining, or permanently implantable devices and those with potential serious health impact if failure occurs.

Q2. Who is responsible for tracking?
Manufacturers bear primary responsibility; importers and distributors must supply required information within ten days of FDA request.

Q3. What information must be tracked?
Device identifiers (UDI, serial, lot), manufacture dates, consignees, and patient implant/removal data when applicable.

Q4. How long must records be kept?
For the expected device life but not less than two years beyond final disposition or patient removal.

Q5. How does Part 821 interact with UDIs?
Device identifiers in tracking systems must align with the UDI framework established under 21 CFR Part 830 for consistent traceability.

Q6. Where can I find the official rule?
See the eCFR: 21 CFR Part 821.

3) How It Relates to V5

V5 by SG Systems Global embeds Part 821-aligned tracking directly into its eDHR and WMS modules, linking device serialization, shipment, and field location data under Part 11-controlled records.

• End-to-end traceability. Track each serial or lot from manufacture through distribution to patient implant site.
• UDI integration. Capture UDI and device metadata automatically through V5 labeling and serialization tools.
• Recall readiness. Rapidly locate affected devices by lot, serial, or patient to comply with Parts 806 and 803.
• Audit trail and sign-off. All tracking updates recorded under Part 11 with timestamp and electronic signature.
• CAPA linkage. Tracking events feed into V5 QMS for investigation and preventive action workflow.

End-to-end example. An implantable device is manufactured and serialized in V5; UDI is printed and captured on shipment; installation and patient assignment are recorded in eDHR; if a recall occurs, V5 instantly identifies every recipient and distributor holding affected units.

Primary References:
• FDA eCFR: 21 CFR Part 821
• Quality System: Part 820 (QSR)
• MDR: Part 803
• Corrections & Removals: Part 806
• Electronic Records: Part 11