FDA Medical Device Labeling Requirements

FDA is very specific about the labeling claims that appear on medical devices. The information permitted on a medical device label is determined by the device class regulations including; FDA class 1, FDA 510(k), or the FDA Pre-Market Approval (PMA). Medical device ‘labeling’ as the term is, as defined by the Food Drug and Cosmetic Act (FDCA), exceeds just the printed label on the device and will encompass all device’s accompanying brochures, manuals, marketing materials and websites. Claims that surpass the clearance, the approval, or the applicable FDA regulation will cause the medical device to leap into an unapproved medical device category and therefore subject to FDA enforcement.

Labeling issues are often the primary cause of delays in FDA approval and import detentions. FDA Listing Inc. team of device labeling experts who have an extensive background in providing labeling reviews will first analyze your label by cross checking it against relevant U.S. federal regulatory databases and FDA labeling guidelines. Next, we will provide you with comprehensive FDA compliant labeling review of your medical devices. The review will be provided in an all-inclusive report format that will include the suggested graphic design and the claim modifications that are ready to be used on the product.


Service & Fees:

  • Current Label’s Review & Assessment, 50 USD
  • FDA Compliant Complete Labeling Service, 1195 USD
  • FDA Compliant New Label Content, 50 USD
  • Sixty Days Label Reviews and Modifications, 50 USD
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