A 510(k) is required when:
1. Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the FD&C Act), anyone who wants to sell a device in the United States is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If the device was not marketed by your firm before May 28, 1976, a 510(k) is required.
2. Seeking a different intended use for a device already in commercial distribution. The 510 (k) regulation specifically requires a premarket notification submission for major changes in intended use. Intended use is indicated by claims made for a device in labeling or advertising. However, most, if not all, changes in intended use will require a 510(k).
3. There is a change or modification of a device that is already being marketed, if the modifications could significantly affect5′ the safety or effectiveness of the device or, if the device is to be marketed for a new or different indication.56 See FDA guidance on determining the significance of a device modification. http://www. fda. gov/cdrh/ode/510kmod. html.