FDA has few to no mechanisms in place to reliably identify companies or products that are flying under their radar. This is not unique to FDA; it's how government oversight agencies tend to work. The IRS oversees taxpayers who self-identify by getting a TIN. The EPA oversees companies who register with them, like device companies register with FDA.
As a result, the most common way FDA hears about these companies and products is through reports from the public--healthcare practitioners, competitors, law firms, patient advocacy groups, etc. Competitor reports are common, for obvious reasons, but other parties with concerns about patient safety are also important sources.
The FDA gets these reports all the time. The Office of Compliance has an Allegations of Regulatory Misconduct Branch that is charged with investigating these reports. OC has a mailbox which has been set up specifically to receive and investigate these reports: OCMedicalDeviceCo@fda.hhs.gov.
However, I would recommend you proceed with caution when it comes to assuming they are engaged in misconduct. It is not always that easy to tell from the outside looking in. If the company does not appear to be registered with FDA, you might start by trying to, first, confirm that they aren't registered and then, if not, determine why not. If they are registered, but the device isn't listed, then I would try to investigate this as well. Sometimes the company is registered and/or the device is listed, but that isn't readily apparent for one reason or another.
You can try contacting the company directly. If you are a competitor, you might not get very far, but at least you will have given them an opportunity to explain before you approach FDA. If they are not in compliance, sometimes the mere fact that someone has inquired will be sufficient to inspire them to get their regulatory ducks in a row.
As others have noted, you probably also want to be sure that your own house is in order before you pursue this type of thing aggressively. And definitely that your management is on board. Companies that are operating well out of regulatory compliance have an unfair competitive advantage. This can jeopardize the financial health of their competitors, and companies have a right to protect their financial health from being undermined by the illegal actions of others. Still, this isn't something to be pursued lightly.
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Julie Omohundro RAC
Durham NC
United States
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