Who is required to submit a 510(k)?
The regulations do not specify who must submit a 510(k) but they specify which actions require a 510(k) submission:
- - Domestic manufacturers introducing a device to the US market;
- - Specification developers introducing a device to the US market;
- - Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
- - Foreign manufacturers/exporters or US representatives of foreign manufacturers/exporters introducing a device to the US market.
Different scenarios further specify the need and can be found on the FDA Website.
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