The FDA’s 510(k) Clearance Process Simplified

Any company that plans to sell a medical device in the United States needs to register their medical devices before marketing their product from the Food and Drug Administration (FDA. The FDA is responsible for regulating the medical device quality systems to ensure the safety of foods, drugs, and medical devices for use in the country.

Medical devices encompass a wide array of tests and equipment and are placed into three different classes based on their potential risks to the public, with Class I carrying the lowest risk, Class II having a moderate risk, and Class III carrying the highest risk. Accordingly, products marked as Class I may be marketed as FDA Listed devices, Class II as “FDA-cleared” devices, and Class III as “FDA-approved” devices. Depending on the medical device’s risk classification category, the product is sold by the medical device companies. Before their product can be sold legally in the United States, manufacturers of Class II medical devices must obtain FDA 510K clearance.

FDA 510K Submission Simplified

The Food, Drug, and Cosmetic Act section 510(k) requires companies planning to sell medical devices in the United States to register before marketing their products. For the manufacturer of the medical devices, in the event that a premarket approval (PMA) is not needed, and unless the device does not fall under the exemption from 510k regulations of the Food, Drug, and Cosmetic Act (FD&C Act), a 510k approval or clearance – also known as a premarket notification (PMN) – must be submitted to the FDA.

The goal of an FDA 510k submission is to show that the device is substantially equivalent to another legally marketed medical device in terms of safety and effectiveness. Devices that are eligible for 510(k) Clearance are those that fall into the FDA’s Class II category.

There is no need for companies to provide clinical trial data related to the safety or effectiveness of the device when submitting a 510(k). The FDA however compares the device to other devices when assessing the device’s safety and effectiveness. The 510(k) application must be submitted to the FDA at least 90 days before marketing the product. FDA 510(k) reviews are typically completed relatively quickly since clinical study data isn’t evaluated. Generally, 510(k) clearances are granted within three months of filing.

510k clearance requires that the manufacturer of the medical device choose a predicate device with the same functionality and technical characteristics, or else with the same intended use as the new device while demonstrating the same level of safety and effectiveness as the predicate device.

To facilitate submission for an FDA 510(k) approval, Companies can take advantage of medical device consulting services from companies like Operon Strategist’s dossier management and product registration solution to establish substantial equivalence and help speed up reviews, clearances, and approvals for FDA 510k clearance.