![]() ![]() market also require FDA 510 (k) submission representatives of foreign manufacturers/exporters introducing a device to the U.S. However, most repackagers or relabelers are not required to submit a 510(k).įoreign manufacturers/exporters or U.S. Operations, such as sterilization, could alter the condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. ![]() Repackagers or relabelers may require FDA 510(k) Submission if they significantly change the labeling or otherwise affect any condition of the device. Repackers or relabelers who make labeling changes or whose operations significantly affect the device. The specification developer submits the FDA 510(k) Notification, not the contract manufacturer. market Ī specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. Specification developers introducing a device to the U.S. Contract manufacturers, those firms that manufacture devices under contract according to someone else's specifications, are not required to submit FDA 510(k). However, manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts. Accessories to finished devices that are sold to the end user are also considered finished devices. The following four categories of parties must submit FDA 510(k) :ĭomestic manufacturers introducing a device to the U.S.market įinished device manufacturers must submit FDA 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Instead, they specify which actions, such as introducing a device to the U.S. The manufacturer should be prepared for an FDA quality system (QSR) inspection at any time after FDA 510(k) clearance.įDA does not specify who must apply for a 510(k). The submitter may market the device immediately after FDA 510(k) clearance is granted. Please note that FDA does not perform 510(k) pre-clearance facility inspections. FDA does not provide approval or certification through 510 k process nor issue a certificate of registration, but you will get a 510 k number. FDA 510(k) is not FDA approval or FDA certification of the medical device, it is only a marketing clearance. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. Once the device is determined to be SE, it can then be marketed in the U.S. Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. ![]() ![]() The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."įDA 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). ![]()
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