510k Premarket Notification Submission, 510(k) document, 510k approval

Premarket Notification

510k Submission

Each manufacturer or distributor who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a PMA is not required, need to submit a 510(k) application unless the device is exempt from 510(k) requirements. Before marketing a medical device, each submitter must obtain a clearance letter from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. The device is thus cleared for commercial distribution.

A 510(k) is a premarket submission to the FDA to show that the device to be marketed is at least as safe and effective to a legally marketed device that is not subject to PMA. Submitters must include a comparison between the intended medical device for approval and one or more similar cleared marketed devices to support their substantial equivalency claims. The legally marketed device(s) to which equivalence is demonstrated is commonly known as the predicate device. Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.

The 510k submitter may not proceed to market the device until the substantially equivalence SE letter is received. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. However, normally this time exceeds 90 days when not all documentation is received by the FDA or if there are additional requests for evidence and the submitter takes time to provide it. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be in compliance with Quality Systems Regulations or current Good Manufacturing Practices so to stay prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.

Who is Required to Submit a 510(k)

The following categories of parties must submit a 510(k) to the FDA:

  • Domestic or foreign manufacturers/exporters introducing a device to the U.S. market. Finished device manufacturers must submit a 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories sold to the end user are also considered finished devices. Medical device component manufacturers are not required to submit a 510(k) unless such components are sold to end users. Contract manufacturers are not required to submit a 510(k) if they do not sale to end users.

  • A firm that provides under contract to a manufacturer the specifications for a finished device. The specification developer submits the 510(k), not the contract manufacturer.

  • Repackagers and relabelers may be required to submit a 510(k) if they change the labeling of the device affecting safety or effectiveness. Labeling changes such as modification of manuals, brochures or promotional materials, that change the intended use, deleting or adding warnings, contraindications, etc, are required to file a 510k.

510k Submission Services

Sigma Biomedical provides complete FDA consulting services for Food and Drug Administration (FDA) 510(k) 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