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FDA Medical Device Registration Assistance

U.S. FDA Medical Devices Registration and FDA Device Listing

Get FDA device registration and device listing services at the lowest fees with an experienced FDA consulting firm. FDA Listing Inc. helps FDA medical device registration, and annual renewal of existing listing information.

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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.

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U.S. FDA Global Device Identification GUDID Unique Device Identifiers UDI

FDA has established a Unique Device Identification system to identify medical devices through their distribution and use in hospitals and other practices. Through this universal system, the label of most devices should include a Unique Device Identifier (UDI) in a human and machine-readable format. FDA also requires Medical Device labelers to submit certain information about each device including UDI to FDA’s Global Unique Device Identification Database (GUDID). FDA Listing Inc. can assist you in deciding if FDA's UDI is required for your device as well as submitting your device information to FDA’s Global Unique Device Identification Database (GUDID). Click the start button for free initial assessment and GUDID submission and UDI assistance.

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FDA 510k Preparations and Submissions

In order for a medical device to be sold in the U.S. market many of medical devices (most Class 2, some Class 1 and 3) are subject to FDA clearance called 510(k) submission process. A 510(k) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is substantially equivalent, to an already marketed device in U.S. The 510(k) submission must compare the device to at least one legally marketed devices and provide support for their substantial equivalency claims.

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FDA Color Additive Requirements

U.S. FDA strictly regulates the color additives that are being used in any part of the manufacturing process of medical devices . All color additives must be properly declared on the product labels. Use of unapproved color additives violates FDA regulations.

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FDAListing.com 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.
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