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FDA Medical Devices Labeling Requirements

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. Fill this form to request for free initial labeling assessment and expert FDA compliant device labeling review.

Check if you registered with FDA.
Submit Results 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