A premarket notification, or 510(k), is submitted to FDA before a manufacturer proposes to
market a medical device. If FDA agrees the new device is substantially equivalent to a legally
marketed device for which premarket approval is not required, the manufacturer may market it
immediately. FDA does not require clinical data in most 510(k)s. However, if clinical data are
necessary to demonstrate substantial equivalence, the clinical study must comply with the IDE,
IRB, and human subject protection (informed consent and additional safeguards for children in
research) regulations.
