FDA GMP Identification & Traceability

LMG provides expert QMS and CGMP consulting to identification and traceability practices

under the QMSR and ISO 13485:2016

21 CFR Part 820GMP ComplianceQMSR RequirementSince 2009

Identification & Traceability Under the FDA QMSR

Since February 2, 2026, medical device manufacturers have operated under the FDA’s Quality Management System Regulation (QMSR), which replaced the earlier Quality System Regulation (QSR). Under the revised 21 CFR Part 820, identification and traceability requirements — previously found in Subpart F (§820.60 Identification and §820.65 Traceability) — are now governed by ISO 13485:2016, Clause 7.5.8 (Identification) and Clause 7.5.9 (Traceability), incorporated by reference through §820.10. Medical device manufacturers who commercially distribute finished devices in the U.S. must maintain identification and traceability practices that comply with ISO 13485:2016, along with the additional FDA-specific requirements the QMSR layers on top.

It is important to note that Unique Device Identification (UDI) is not part of ISO 13485 — it remains a distinct FDA requirement under 21 CFR Part 830 and §801.20, which the QMSR continues to require through §820.10. Manufacturers must therefore meet both the ISO 13485 identification and traceability clauses and the FDA’s separate UDI obligations.

Robust identification and traceability are essential for product control, complaint handling, and recall readiness. LMG provides expert QMS and CGMP consulting to help you build, document, and maintain compliant identification and traceability practices under the QMSR and ISO 13485:2016, including:

Product identification throughout production and distribution
Component and raw material identification
UDI (Unique Device Identifier) requirements
Traceability records for implantable devices
Lot/batch identification for recall purposes

LMG assists medical device manufacturers with QMSR and ISO 13485:2016 gap assessments, procedure and document development, UDI and labeling compliance support, and audit and inspection readiness — helping you transition from the legacy QSR and stay compliant under the new Quality Management System Regulation.

Frequently Asked Questions

Common questions about this FDA QMSR Identification & Traceability.

Does the QMSR eliminate UDI?

No — and this trips people up. UDI was never part of ISO 13485, so it doesn’t disappear when Part 820 adopts the standard. It stays exactly where it was, under 21 CFR Part 830 and §801.20, and the QMSR keeps requiring it. You now have two things to satisfy: the ISO 13485 identification and traceability clauses and your separate FDA UDI obligations.

Do I still have to trace components and lots the way I did before?

Essentially, yes. ISO 13485:2016 Clauses 7.5.8 and 7.5.9 cover the same ground the old §820.60 and §820.65 did — identifying product through production and distribution, and maintaining traceability records. If your existing system was solid under the QSR, the core practices carry over; what changes is the language and the regulation you point to.

I only make implantable devices — does anything change for me?

Your traceability obligations remain stringent, since implantables are exactly the category ISO 13485 singles out for the highest level of traceability. The practical difference is mostly documentation: procedures and records should now reference ISO 13485 Clause 7.5.9 rather than §820.65, and your UDI handling still follows FDA Part 830 on top of that.