Instead of specifying who to apply for 510(k), the Act and 21 CFR Part 807 specify the required actions for 510(k) submission.
However, the below mentioned categories of parties should submit a 510(k) to the FDA:
- Domestic manufacturers introducing a device to the U.S. market;
- Specification developers introducing a device to the U.S. market;
- Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
