Unlike prescription drugs, it is not illegal per se to import foreign-sourced prescription medical devices or to reimport U.S.-made and exported prescription medical devices. Although legal, the process of reimporting or importing foreign-sourced prescription medical devices must be carefully examined and documented each time to make sure no violation of U.S. laws occurs. Many people do this incorrectly and find themselves the target of a federal or state-based criminal indictment. This is unfortunate, because reimporting or importing foreign-sourced prescription medical devices can be legally accomplished if it is done very, very carefully.
Is it Counterfeit?
Often, because of the significantly lower prices available in foreign markets, imported prescription medical devices frequently present an attractive alternative to the domestic option. Buyers of foreign products must be careful and exercise rigorous due diligence before purchasing them to avoid running afoul of the U.S. Food and Drug Administration (FDA) or U.S. Customs and Border Protection authorities. These products may be counterfeit versions of FDA-approved medical devices, or they may be legitimate-but-unapproved versions actually made by the brand owner, but not allowed for sale in the United States. In either instance, the FDA and/or Customs could take a series of enforcement actions against the importer, the device, or later purchasers and marketers of the devices.
The U.S. FDA does not have a general ban against importing or reimporting prescription devices, but it evaluates many imported medical devices to make sure they are permissible for sale in the United States. Because of this, it is crucial to do it correctly. The FDA proactively monitors imported device shipments to verify compliance. If a device got through the FDA's import process, it doesn't mean that the device is legal. This must be ensured by the person selling, buying and using the device. The fact that the FDA allowed it over the border will not be a defense if you buy, sell, import, distribute or use a counterfeit or unapproved medical device.
The FDA is aware of a few key concerns that make imported devices particularly vulnerable to noncompliance. First, it is unfortunately common for unscrupulous people to sell counterfeit prescription devices. Second, legitimate product must be:
- In the form that the FDA approved for clearance
- From an FDA-approved (and -registered) facility that listed the device correctly, and that bears the proper labeling approved for the United States
Many of the same devices are cleared for different-and additional-indications in the European Union, Canada, and Mexico. Therefore, the labeling of devices obtained from those markets is almost always in violation of FDA regulations and the laws the FDA enforces.
To ensure the quality and compliance of all products, a company should only purchase from established, reputable sources and, at the very least, obtain a product pedigree. After receiving the product, be sure to examine the label for any indication that it may not be legitimate. One clue would be if the manufacturer declared on the label is not the manufacturer that has listed the device with the FDA in its own registration. Be sure to check this out. (This information can be found on www.fda.gov/MedicalDevices.) It is important to take the proper steps to ensure that you are receiving legitimate product. Otherwise, in seeking to save a little money, you may find yourself with no money, no product and an FDA officer inquiring into your purchases.—Benjamin L. England
Benjamin L. England, Esq., founder and CEO, Benjamin L. England & Associates, LLC, and FDAImports.com, LLC, routinely represents domestic and foreign companies of all sizes, assisting them in identifying FDA, USDA, FTC, EPA, and state requirements. His representation enables his clients to better understand and fully comply with federal and state requirements, and thereby reduce the risk of regulatory interference with products being imported, exported, or distributed in interstate commerce.