03 Nov

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. See section 520(g) of the act and 21 CFR Parts 812, 56 and 50. 

Source: USFDA

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