Medical Devices | Labeling Requirements

Medical device labels must comply with all FDA labeling requirements. The information permitted on a medical device label is dictated by the regulations governing the device (where the device is already classified as a Class 1 device), the FDA 510(k) clearance, or the FDA Pre-Market Approval (PMA) if one is required. FDA is very specific about the labeling claims that may appear on medical devices. Claims that exceed the clearance, the approval, or the applicable regulation will cause the medical device to fall into an unapproved medical device category. Unapproved (mislabeled or misbranded) medical devices are subject to FDA recall (mandatory recall), FDA import detention, FDA Import Alerts, and FDA import refusal of admission.

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Internet sites used to market and sell medical devices are often considered ďlabelingĒ 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 the regulation, medical device 510(k) clearance or FDA approval. Excessive or impermissible claims will cause the medical device to be regulated by FDA as an unapproved medical device. FDA often reviews company websites looking for claims that exceed FDA regulations, clearances, or approvals.

FDAImports.com, LLC helps every type of client develop correct, lawful medical device labels and labeling (Internet site and advertising) claims. This requires FDAImports.com, LLC to review the medical device, its applicable regulations, and the applicable medical device clearances or approvals and to understand the manufacturerís, distributorís or marketerís business interests and target market for the device. FDAImports.com, LLC assists companies in designing legal and effective marketing claims for medical devices imported into the U.S.

If you are simply starting up 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.