Medical Devices | Labeling Requirements

The information permitted on a medical device label is dictated by the regulations governing the device. Device labels must contain a Unique Device Identifier (UDI). This is a special bar code, unique to each medical device. FDA is also very specific about the labeling claims that may appear on medical devices. Devices with labels that do not include a UDI or with claims that exceed regulatory limitations may fall into an unapproved category. Unapproved devices may be subject to FDA recall (mandatory recall), FDA import detention, FDA Import Alerts, and FDA import refusal of admission. Medical device labels must comply with all FDA labeling requirements.

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Internet sites used to market and sell medical devices are often considered “labeling” as that term is defined by the Food Drug and Cosmetic Act (FDCA) and FDA regulation. Therefore, it is important to ensure that Internet sites used to market medical devices do not make claims that exceed their regulatory limitations. Excessive or impermissible claims will cause the medical device to be an unapproved medical device. FDA often reviews company websites looking for claims that exceed FDA regulations, clearances, or approvals.

FDAImports.com, LLC helps clients obtain UDIs and develop labeling (including websites and other advertising) claims that meet regulatory requirements. This requires FDAImports.com, LLC to review the medical device, its applicable regulations, and the medical device clearances or approvals.

If you are a startup or contemplating a new venture and would like to know the expenses, timeframes and possible business risks, talk to us. If you are a multi-national firm that has completed this process before, we can help you as well. FDA Imports.com, LLC is a full-service regulatory consulting firm with consultants and affiliated attorneys with substantial expertise and experience in the field of FDA medical device and Federal Trade Commission (FTC) advertising and marketing regulations. Let us show you The Way Through the legal maze of medical device labeling and advertising on the internet.

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States.Get Started.