510k

510k is a premarket notification submitted to the U.S. Food and Drug Administration (FDA) by a manufacturer seeking clearance to market a medical device in the United States. The submission argues that the new device is substantially equivalent to a legally marketed predicate device. If FDA finds substantial equivalence, the device is cleared for marketing. The 510k pathway is the primary route for many Class II devices and for some Class I devices; certain devices may be exempt from 510k requirements or may pursue a De Novo classification or Premarket Approval (PMA) instead.

The 510k program includes traditional 510(k), abbreviated 510(k), and Special 510(k). Traditional 510(k) is the standard route with full data. Abbreviated 510(k) relies on recognized standards and existing guidance to streamline review, often reducing data requirements. Special 510(k) is used to make changes to an already cleared device when testing and documentation suffice to demonstrate continued safety and effectiveness.

Substantial equivalence requires that the new device have the same intended use as the predicate and that its technological characteristics are similar enough that any differences do not raise new questions of safety and effectiveness. If FDA determines that a device is not substantially equivalent, the sponsor may pursue the De Novo classification process for novel devices or, if appropriate, a PMA.

Submissions typically include device description, intended use, labeling, and performance data from bench testing, biocompatibility, sterilization, and software validation if applicable. Clinical data are not routinely required, but may be needed in certain cases. After clearance, devices must comply with postmarket requirements such as quality system regulation, adverse event reporting, and potential postmarket surveillance.