Standardized service

Primary / Secondary Device Label Review

We review primary and secondary device labels against FDA labeling regulations (21 CFR Part 801 and related rules), flag non-compliances, and recommend corrections — reducing misbranding and port detention risk.

RegulatorU.S. FDA

Primary Basis21 CFR Part 801

Initial ReviewAbout 2-3 weeks

DeliverablesFindings list and suggested label draft

On this page

What this service is

FDA labeling requirements for medical devices are mandatory, grounded mainly in 21 CFR Part 801 and device-specific classification regulations. Non-compliant labeling constitutes misbranding and can lead to detention, warning letters, or recall.

The FDA does not approve labels before marketing; it samples products after launch. Primary labels (immediate container/device label) and secondary labels (outer packaging) carry different mandatory information, and both must meet the applicable requirements — including the UDI carrier, manufacturer identification, intended use, and required warnings.

FD&C Act §50221 CFR Part 801

Who needs it

Device manufacturers and labelers preparing to export to the U.S.

Companies with English labels that need a compliance check before printing or shipping

Companies responding to FDA or customer feedback on labeling issues

Prerequisites and sequence

Device classification and product code are confirmed (labeling requirements differ by classification).
A readable version of the current labels is available (artwork or text draft both acceptable).
If the device has 510(k) clearance, label content must match the cleared intended use.

Who holds regulatory responsibility

Labeling compliance rests with the labeler. We provide a technical review against regulations and FDA guidance with correction recommendations; you decide on and take responsibility for the final label.

Materials we need from you

Current versions of primary and secondary labels (artwork or Word text draft)

Intended use and claims description

510(k) number and cleared indications wording (if applicable)

UDI code and carrier format (if already assigned)

Process

01
Confirm device classification and the applicable labeling provisions
02
Check mandatory statements, typography, and information order item by item against a checklist
03
Verify that claims match the intended use and any cleared information
04
Issue an action-point list with correction details per item
05
Provide a suggested corrected label draft for implementation

Deliverables

Label review findings list with regulatory references

Annotated label with correction comments

Suggested corrected label draft (ready for your team to implement for printing)

Timeline

The initial review is typically completed about 2-3 weeks after receiving complete materials; follow-up rounds depend on how quickly corrections are implemented.

Scope

What we provide

Regulatory compliance review of primary and secondary labels
Claims-to-intended-use consistency check
Findings list and correction recommendations
One round of post-correction re-review

What is not included

Graphic design and layout production (handled by you or your designer)
Detailed IFU review (a separate service)
Multilingual label translation

What usually follows

IFU Review UDI Device Submission

Common pitfalls

Expecting the FDA to pre-approve your labelThe FDA does not approve labels before marketing; it samples products after launch, and non-compliance leads to published warning letters or detentions. Fixing issues after FDA action costs far more than a pre-launch review.

Claims exceeding the cleared intended useLabel claims must match the device's intended use and any 510(k) cleared wording. Inflated or broader claims constitute misbranding and can lead to detention, warning letters, or recall.

Reviewing only the primary label and skipping secondary packagingPrimary labels (immediate container/device) and secondary labels (outer packaging) carry different mandatory information; both must be checked. Reviewing only one still leaves the shipment exposed to port detention.

Not checking each pack configuration separatelyEven for the same product, different pack sizes can change mandatory statements such as quantity and UDI. Reusing one label version across configurations copies errors into every variant.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Will the FDA approve my label in advance?

No. The FDA samples marketed products; non-compliant labels can trigger warning letters or detentions that are published. A third-party label review before launch is a common way to reduce this risk.

Should labels for multiple models or sizes all be reviewed?

Yes, we recommend it. Even for the same product, different pack configurations can change mandatory statements (size, quantity, UDI), so each label should be checked separately.

Can you design the label for us?

We do not do graphic design. If you provide an editable version, we can annotate corrections and supply a compliant suggested draft; final artwork should be produced by your designer.

Related services

IFU ReviewWe review device instructions for use (IFU) and user manuals, checking that indications, contraindications, warnings, operating steps, and post-market information align with FDA requirements and your device filings.Device ListingAfter establishment registration, every device marketed in the U.S. must be listed with the FDA, declaring its product code, proprietary name, and premarket submission number. Listing is handled per device, and we complete each filing with you.UDI SubmissionWe help the labeler submit each device's DI data to the FDA GUDID database. This service is scoped per group of up to 5 devices, with additional devices arranged separately — suited to first submissions or smaller portfolios.

Disclaimer

Label review comments reflect a general reading of current regulations and FDA guidance. They are not legal advice and cannot guarantee the FDA will raise no other issues.