510k Submission: Before marketing a medical device or health product in the US, or reintroducing a device that has been modified affecting safety or effectiveness, manufacturers or parties of interest need to submit to the Food and Drug Administration FDA a pre market notification PMN or 510(k) and demonstrate by performance data, safety testing and product documentation that it is substantially equivalent to an already marketed device and that no new safety or effectiveness concerns are introduced. A medical device is not considered to be "approved" by the FDA but rather "cleared" for marketing, which means it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices.

510(K) Review Process: The FDA 510(K) submission and review process allows the FDA to determine whether the device is equivalent, in terms of intended use, technology, safety and effectiveness, to a device already cleared for marketing. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, labeling or intended use.

In case there is no equivalent product cleared for marketing in the US, a request for a new device classification need to be submitted. Performance data and safety test reports are part of the 510(K) documentation that needs to be submitted. Performance data is aimed to demonstrate the device performs as expected and equivalent to predicate or similar devices. Safety testing is aimed to verify that the device and its operation will not raise safety concerns to the patient. The specific testing depends on the type of medical device, its risk level, and applicable regulations.

Timing: Section 510(K) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. Normally, it takes few months to prepare the complete documentation and performance data as required by the FDA. The 510(K) process once the documentation is submitted may take about 90 days to obtain the SE Notice from the FDA.

510(K) Clearance: The link to the FDA releasable database of 510(K) clearance can be found here.

Our services: Sigma Biomedical provides complete FDA 510K consulting services for medical device submissions, as well as for other medical regulatory affairs needs, such as FDA Quality System Regulations QSR compliance. Sigma's regulatory, engineering and scientific team can efficiently help you register your product with the FDA.