Medical device labeling errors—from false claims and missing warnings to off-label promotion and UDI mistakes—are among FDA’s top enforcement triggers. Learn common pitfalls and practical steps to ensure compliance and avoid costly misbranding risks.
Medical device companies can learn a lot from past mistakes – many FDA warning letters and inspection reports show the same labeling and advertising problems occurring again and again. Below are some of the most common labeling violations and practical advice on how to avoid them in your organization
One of the top reasons devices get labeled misbranded is the inclusion of false or misleading statements in labeling or advertising. This could be an overhyped efficacy claim (“95% success rate!” without evidence), an unproven superiority claims against a competitor, or calling the device “FDA approved” when it’s only cleared or exempt.
Avoidance Tip: Stick to factual, demonstrable claims in your labeling. Ensure any statistical claims are backed by legitimate data. Never claim or imply FDA endorsement or approval that you don’t have – for 510(k)-cleared devices, using “FDA Approved” is actually incorrect and considered misleading. Train marketing teams to be precise with language (e.g., use “cleared” or “authorized” if that is the correct term). Internally vet all claims through regulatory or legal review before they go public.
Another frequent violation is missing mandatory labeling content, such as failing to list the manufacturer’s name and address, or not including the net quantity of contents on the package. Every device, unless exempt, must display these basics.
Avoidance Tip: Use a compliance checklist for label design that includes all elements required by 21 CFR 801. For instance, confirm that the final artwork has a placeholder for firm name/address, a field for quantity (if applicable), the device’s common/usual name, any required symbols or codes (like UDI), etc. It sounds simple, but something like a missing address has occurred in warning letters. Also, remember language requirements – in the U.S., information must be in English (with exceptions for territories), so ensure translations (if used for other markets on a combined label) do not result in any required info being present only in a foreign language without English equivalent.
As discussed earlier, not providing adequate directions for use for an OTC device, or not including the proper prescription device labeling (like “Rx only”), is a common pitfall. FDA has cited firms for selling devices to consumers without sufficient instructions, making the products dangerous or useless.
Avoidance Tip: Draft clear, step-by-step Instructions for Use (IFU) for any lay-use device and test them with actual users if possible. If the device is prescription-only, double-check that all labeling carries the “Rx only” designation and that the promotional materials do not make it look like an OTC product. If you find an OTC device’s instructions are too complicated or risky for a layperson even with a manual, that’s a red flag – perhaps it should be Rx or you need to redesign for usability.
Many labeling violations involve failure to include important warnings, precautions, or contraindications. For example, if a device has not been tested on children but the labeling doesn’t warn against pediatric use, that omission can be seen as a violation (the labeling could be considered misleading by omission).
Avoidance Tip: Compile a list of all known risks, side effects, and user limitations from your device’s risk management file and clinical data. Make sure the labeling addresses each with either a warning, caution, or note as appropriate. Compare your warnings with similar devices’ labeling – are you missing something others include (like “Not for use in patients with pacemakers” or a latex allergy warning if parts contain latex)? Also ensure warnings are prominent in the labeling. Burying a critical warning in fine print in the back of a manual might not satisfy FDA that you’ve adequately conveyed it.
A very common theme in enforcement is companies marketing devices for off-label uses or broader populations than approved. This might show up in the form of brochures, websites, or even the intended use statement on the label being too broad. For example, labeling a device as a general treatment for arthritis when it’s only cleared for knee pain is an off-label promotion via labeling.
Avoidance Tip: Rigorously ensure that your labeling content (indications, instructions, and marketing blurbs) matches the exact uses cleared by FDA. If you find sales or marketing materials drifting into new territory, reel them back in. Conduct periodic training refreshers on what your device is not approved to do. If your team feels constrained because customers want that off-label use, consider initiating an FDA submission to expand the indication – but don’t jump the gun by advertising it beforehand. Remember, promoting off-label = misbranding, and FDA has shown willingness to penalize it.
With the UDI requirements now in effect, a compliance issue seen is devices lacking a proper UDI on the label or having an incorrect UDI. An audit or inspection could cite a firm if, say, Class II devices on the market have no UDI or if the UDI data isn’t properly submitted to GUDID.
Avoidance Tip: Audit your own product lines to verify all required products carry UDIs. Have someone scan the barcode and verify it decodes to the correct DI + PI values. Also, check that your GUDID entries are up to date for those devices. It’s wise to have a procedure that whenever a label change is made, UDI presence is verified and any necessary database updates are done. Maintaining compliance with UDI will also help avoid field issues like misidentified products in hospitals.
Beyond what’s on the label, how labels are controlled can lead to violations. A common problem is mislabeling – e.g., a label for Product A accidentally put on Product B’s package. FDA’s Quality System Regulation requires companies to control labeling operations to prevent such errors. If mislabeling occurs, it can result in a recall and citations.
Avoidance Tip: Implement robust label controls: barcode scanning or vision systems during packaging to confirm the right label, line clearance procedures, and final label inspection. Also keep revision control of labeling – if an old version with a mistake was supposed to be replaced, ensure the old stock is destroyed. Many warning letters have stemmed from companies failing to remove obsolete or incorrect labels from use.
In summary, avoiding common labeling violations comes down to diligence and a strong quality culture. Utilize checklists, peer reviews, and testing to ensure your labeling is complete and correct. Conduct internal audits focusing on labeling compliance. Monitor FDA warning letters or safety notices for devices similar to yours – they often highlight issues that you can proactively check in your own labeling. And whenever in doubt, consult the regulations (21 CFR 801), FDA guidance documents, or even ask FDA’s device division for clarification. It’s far better to catch and fix a labeling issue early than to face a public recall or warning letter later.
