Failing to register your establishment or list medical devices with FDA can trigger misbranding status, warning letters, import detentions, and lost market access. Non-compliance risks legal action, reputational damage, and costly business disruptions.
Compliance with FDA’s registration and listing requirements is not just bureaucratic red tape – it’s the law. Failure to properly register your establishment or list your devices can lead to serious regulatory and business consequences. Here we outline what can go wrong if these requirements are ignored or overlooked:
Under the Food, Drug, and Cosmetic Act, a medical device is deemed misbranded if it is manufactured in an establishment that has not duly registered, or if the device is not included in the required device listing. This is spelled out in Section 502(o) of the Act and related regulations. In plain terms, if you sell a device in the U.S. and you (as the manufacturer) didn’t register or list it, your product is on the wrong side of the law. Misbranding is a prohibited act – FDA can take enforcement action at any time for selling misbranded devices.
FDA has the authority to inspect device companies and request proof of registration and listing. If an investigator finds that a firm hasn’t registered/listed, it will be a significant inspection observation (likely on the FDA Form-483 issued at inspection’s close). This often leads to a Warning Letter from FDA. For example, in one Warning Letter excerpt, FDA stated: “All of your firm’s devices are misbranded… in that the devices were manufactured in an establishment not duly registered under section 510 of the Act and were not included in a list required by section 510(j)”. The letter went on to say that due to the serious nature of these violations, the firm’s devices were subject to refusal of admission into the U.S.. In that case, FDA essentially put the company on the “red list” for imports (detention without physical exam) until they corrected the registration issue. Warning Letters become part of the public record and can seriously tarnish a company’s reputation, not to mention halt sales.
FDA can also invoke other penalties:
One of the most immediate consequences for unregistered firms is at the border. FDA closely monitors imports of medical devices. If either the foreign manufacturer or the U.S. importer is not properly registered/listed, FDA will detain the shipment. This often happens electronically – when the customs entry is filed, FDA’s system (PREDICT) checks the provided registration and listing numbers against its database. If there’s no match (say, the manufacturer name comes up but they didn’t register for the current year, or the product code isn’t listed by that firm), the shipment gets flagged. FDA may then issue a Notice of FDA Action, detaining the goods. The products will sit in a bonded warehouse or at port while the compliance issue is resolved (if it can be resolved).
Even worse is being placed on an Import Alert. FDA Import Alert #99-34 specifically covers firms that attempt to import devices without proper registration or listing. It essentially tells FDA field staff to automatically Detain Without Physical Examination any devices from those firms. If you get on this red list, every shipment will be stopped until you demonstrate compliance and petition to get off the alert. Import alerts are public, which means your customers or competitors can see that your company is flagged for violations – not good PR.
For example, consider a foreign manufacturer who didn’t realize they had to register. Their first shipment to the U.S. gets detained. FDA informs them (likely via their U.S. Agent) that because they have no registration, the product is refused entry as illegal. The shipment either has to be re-exported or destroyed at the importer’s expense. Meanwhile, the manufacturer scrambles to register after the fact. They may get it done and then request FDA release the shipment, but that process can take weeks. In many cases FDA will not release a detained shipment at all if it arrived when the firm was not in compliance – even if you register the next day, they might insist you export the detained batch and import a new batch after compliance. Thus, the company faces huge delays, extra shipping costs, and possibly lost orders. It’s a painful (and costly) lesson.
Beyond direct FDA enforcement, failing to register/list can have ripple effects:
A UK-based device company failed to complete its annual registration renewal for 2016. FDA discovered this during an inspection and also noted multiple other compliance issues. In the Warning Letter that followed, FDA not only cited quality system violations but also hammered on the failure to renew registration (and pay the fee) as a serious offense. FDA then took the step of refusing entry of all that firm’s products into the U.S. until the issue was fixed, i.e., detention without physical exam. The firm’s devices were essentially banned at the border, which surely got management’s attention. Only after the firm paid the fee, completed the registration, and responded sufficiently did FDA relent. This illustrates that FDA views not registering as on par with significant quality defects – it’s not a minor paperwork lapse in their eyes, it’s a fundamental requirement.
It’s rare, but note that the FD&C Act provides for criminal penalties (misdemeanors, or worse if there’s intent/fraud) for individuals who cause a prohibited act (like commercializing misbranded devices). If a company willfully avoids registration and, say, there’s an injury or public health issue, company officers could theoretically face liability. Typically, that’s not the route FDA takes for simple registration issues, but it underscores the point that non-compliance is taken seriously.
In summary, failing to register and list is playing with fire in the FDA world. The consequences range from immediate trade interruptions (shipments held or refused) to formal enforcement actions that can cripple your business. The cost of compliance (the annual fee and the administrative effort) is minimal compared to the costs of a product hold, a recall, or a legal battle with FDA.
If you realize you have failed to register or list when you should have, the best course is to rectify it immediately – get into compliance, and if FDA has already noticed, be proactive in communication. In many instances, once you fix the issue (pay the fee, submit the info) FDA will lift import alerts or not pursue further action, especially if no harm occurred. But the longer you operate in violation, the greater the risk.
