Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 8071.

The general basis for a 510K is to identify a device that is substantially equivalent to the market’s device, known as a predicate. The marketed device and predicate device shall be compared in a 510K submission. It is a best practice to find a primary predicate device to the future marketed device with similar indications of use and technological characteristics to the marketed device to have a guide for the 510K submission.

The FDA device-specific guidance documents are a great tool to help describe the information that must be incorporated into the 510K submission. There are specific guidance documents for formatting a traditional and abbreviated 510K. All 510Ks must be submitted in an electronic format to the FDA. The medical device submission information is shared with the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) Document control centers.

After the electronic submission of the 510K, the company should monitor its 510K submission with the FDA. The FDA requires a Medical Device User Fee for all 510K submissions and once the fee is paid the FDA will officially begin review of the 510K submission. The Medical Device User Fee may be waived under certain circumstances such as emergency approvals. If you need assistance with your Premarket Notification 510K submissions, EMMA International is here to help with medical device approvals and identification. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

______________________ [1] U.S. Food & Drug Administration (September 2019) How to Prepare a Traditional 510K, Retrieved on May 16, 2022, from https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-traditional-510k

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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