Neither the FDCA or the 510(k) regulations50 specify who must apply for a 510(k)— anyone may do so. Instead, they specify the requirements and actions that must occur prior to introducing a device to the US market. The individuals required to file a 510(k) can be categorized as follows: [6] [7]
3. Repackers or relabelers who make labeling changes, or whose operations
significantly affect2 the device.
4. Foreign manufacturers/exporters or US representatives of foreign manufac – turers/exporters introducing a device to the US market.