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FDA Medical Device Labeling Requirements


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's.


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 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. Click the front start botton to request for free initial labeling assessment and expert FDA compliant device labeling review.

FDA Medical Device Labeling Requirements 

To request a quote about "FDA Medical Device Labeling Requirements" submit US FDA Registration Help form or call us at +1 929-376-7870 to speak with one of our agents for help.

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Contact Info:
Address:82 Nassau St,New York,NY 10038,USA
Phone: +1 929-376-7870


Service & Fees:

  • Current Label's Review & Assessment, Free
  • FDA Compliant Complete Labeling Service, 995 USD
  • FDA Compliant New Label Content, Free
  • Sixty Days Label Reviews and Modifications, Free Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.

U.S. FDA Registration and Listing Inc

82 Nassau St, New York,
NY 10038, USA
Phone: +1 929-376-7870
Email: info