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Fees: Medical Device 510(k) Administrative Review & Submission Service
Many medical devices require clearance by the U.S. FDA before they can be sold in the United States. To obtain this clearance, companies must file an application and exhibits to demonstrate that the device is substantially equivalent to a device already legally marketed in the U.S., including substantial scientific and technical information.
Registrar Corp's 510(k) Administrative Review and Submission Service provides verification of the structure, format and content of your 510(k) submission to help prevent incomplete submissions and costly delays. Registrar Corp will also communicate directly with the U.S. FDA on your behalf. Registrar Corp's 510(k) Administrative Review and Submission Service process is as follows:
Registrar Corp will review your device labeling (including labels, inserts, manuals, etc.) and perform a graphic re-design of your medical device labeling. Additionally, Registrar Corp will assist with the structure, format and content of your 510(k) application * The fee for this is US$ 6,990.
Once your 510(k) is ready, Registrar Corp will submit your application directly to the FDA. At that time, FDA will require a government user fee of US$ 4,007 for 2010.
When your 510(k) application is cleared by the U.S. FDA, you may list your device with U.S. FDA (and register your establishment if not already registered). Note: Registrar Corp can do this for you as your U.S. Agent and/or your Official Correspondent for an additional fee.
To begin your 510(k) Administrative Review and Submission, simply click the link below:
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Registrar Corp's 510(k) Administrative Review and Submission Service does not include an evaluation of your science, data, technology, or predicate device selection.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
