The Labeling Section FDA Wrote Itself (Because ISO Wasn’t Enough)

By now you’ve seen the pattern. The QMSR’s structure is built around a core insight: ISO 13485:2016 already covers most of what a good quality management system needs, so instead of FDA rewriting everything from scratch, the regulation largely points to the standard. Most of Subparts C through O are reserved — replaced by references to specific ISO 13485 clauses.

But not everything. There are two places in the QMSR where FDA looked at ISO 13485 and said, this isn’t quite enough. One of them is §820.35 (control of records, covered in the last post). The other is §820.45: Device Labeling and Packaging Controls.

When FDA puts something in its own words instead of deferring to ISO, it’s a signal. These are the requirements FDA considers essential enough — and specific enough to U.S. regulatory expectations — to write directly into the Code of Federal Regulations. §820.45 is worth your attention.

Why FDA Kept This Section Out of ISO’s Hands

ISO 13485:2016 addresses labeling as part of its general production and service provision requirements (Clause 7.5.1). The standard requires that you control labeling — but FDA’s view was that it doesn’t get specific enough, particularly around inspection. The QMSR Final Rule preamble is direct: FDA does not find ISO 13485’s requirements for device labeling and packaging controls to be adequate.

The evidence for that concern is concrete. FDA has documented, year after year, that a significant share of device recalls are related to labeling and packaging errors: wrong label applied, correct label applied to the wrong device, label content that doesn’t match what’s in the package, packaging integrity failures. These are not hypothetical risks. They are recurring patterns in the recall database, and they have real consequences for patients.

So §820.45 exists because ISO 13485 leaves the room where recalls happen underspecified, and FDA decided not to leave it that way.

What §820.45 Actually Requires

The section builds on — but does not replace — ISO 13485 Clause 7.5.1. Think of it as layered: you still need to comply with ISO’s production requirements, and then §820.45 adds specific FDA requirements on top of that foundation.

The core requirements break down into a few clear areas:

Documented procedures for labeling and packaging operations. Manufacturers must document and maintain procedures describing labeling and packaging activities in sufficient detail to ensure integrity, inspection, storage, and operations throughout processing, storage, handling, distribution, and use. This isn’t new — but under the QMSR the documentation bar is explicit, not implied.

Inspection for accuracy prior to release or storage. This is the heart of §820.45 and where the section earns its keep. Before labeling or labeled devices are released for use or sent to storage, they must be examined for accuracy. Specifically, the examination must confirm:

• The correct Unique Device Identifier (UDI) or Universal Product Code (UPC)
• Any other device identification(s) specified in the medical device file

The UDI callout is notable. UDI compliance has been a separate regulatory obligation for years, but §820.45 explicitly ties it into your quality system controls. Getting the UDI right isn’t just a labeling compliance matter anymore — it’s a QMS inspection step with documentation requirements attached.

Prevention of mix-ups. Labeling and packaging operations must be established and maintained specifically to prevent mix-ups. This means examining labeling and packaging before use to confirm every device has correct labeling and packaging as specified in the device file. It’s an active control requirement, not just a passive documentation obligation.

Documentation of inspection results. Results of labeling inspections must be documented in accordance with ISO 13485 Clause 4.2.5 (control of documents). This creates a traceable record that inspection occurred, what was checked, and whether it passed.

What Changed from the Old QSR

If you’re familiar with the pre-2026 Quality System Regulation, you operated under two separate labeling sections: §820.120 (Device labeling) and §820.130 (Device packaging). The QMSR consolidates both into §820.45 — fewer sections, same essential substance.

The old §820.120(b) required that labeling be examined for accuracy, including with respect to specific device identification elements. §820.45 carries that requirement forward — and updates it to explicitly name UDI and UPC, reflecting the decade of UDI implementation that happened after the QSR was written.

One language change is worth noting: FDA revised §820.45(c) to remove the word “immediately” in reference to when labeling inspection must occur. The old QSR required inspection to happen “immediately” before labeling operations began. Removing that word gives manufacturers slightly more flexibility in how they structure their processes — the inspection just needs to happen prior to use, not at a specific moment in the production sequence.

That’s a small change in language, but it’s a meaningful one for manufacturers with complex or automated production environments where “immediately before” was sometimes difficult to define precisely.

The ISO 13485 Connection

For manufacturers already operating under ISO 13485, the labeling and packaging requirements in Clause 7.5.1 will be familiar. You have documented procedures. You control your labeling operations. You have records.

What §820.45 adds, specifically, is the FDA-required inspection step with explicit UDI verification, and the express requirement to document that inspection. Your ISO-conformant QMS covers the framework; §820.45 fills in what the standard left unspecified about the inspection itself.

If your current label inspection process is thorough but underdocumented — meaning it happens but the records are thin — that’s where §820.45 will push you to improve.

What You Actually Need to Do

For most manufacturers who operated under the QSR, §820.45 shouldn’t require wholesale change. The requirements aren’t dramatically different from what was in §820.120 and §820.130. But a few things are worth verifying:

First, confirm that your label inspection procedure explicitly covers UDI/UPC verification. If your current procedure references device identification in general terms but doesn’t name UDI specifically, update it. This is now an explicit regulatory requirement, and an inspector looking at your labeling controls will expect to see it addressed.

Second, ensure your inspection records are substantive — not just a checkbox that says “labeling inspected.” The requirement to document results in accordance with ISO 13485’s document control requirements means the records need to be traceable, retrievable, and meaningful.

Third, verify that your procedure addresses both release and storage scenarios. The requirement covers labeling examined “prior to release or storage where applicable” — both triggers matter.

And if you have automated label application systems that skip or abbreviate visual verification on the assumption that automation is sufficient: §820.45 is worth a second look. FDA’s explicit preference for visual verification of label accuracy reflects hard-won experience with what automated systems can miss.

The Last Word (For Now)

§820.45 isn’t the most complex section in the QMSR. But it occupies a specific position: it’s one of the two sections where FDA looked at ISO 13485, found it wanting, and wrote its own requirements. That distinction matters. It means FDA inspectors will be paying close attention to how you’ve implemented these controls — because FDA specifically decided not to trust the standard alone here.

The good news is that the requirements are clear, the expectations are specific, and most manufacturers who ran solid labeling programs under the old QSR are already doing most of this. The question is whether your documentation reflects it.

That wraps up Subpart B — which means we’ve now covered every substantive section of the QMSR. For the full series, start with The QMSR Is Here, or jump to any section via the links in that post.

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