A 510(k) is required when:
1. Marketing a device for the first time. A 510(k) is required if your device was not marketed by your firm before May 28, 1976 (the effective date of the Medical Device Amendments to the FDCA).
2. You propose a different intended use for a device that you already have in commercial distribution. Intended use is indicated by claims made for a device in labeling or advertising. The FDA’s position is that most, if not all, changes in intended use will require a 510(k), including a change from prescription use to over the counter use.
3. There is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. The burden is on the 510(k) holder to decide whether or not a modification could significantly affect safety or effectiveness of the device.
