Following information are taken from this FDA guidance:
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).
The draft guidance documents apply to medical devices the FDA clears through premarket notification; manufacturers submit a “510(k)” document that demonstrates the device is substantially equivalent to another marketed device not subject to premarket approval (PMA).
The draft recommendations describe how manufacturers should consider the risk presented by the device modifications when determining if they should submit a new 510(k). When finalized, they will replace an earlier guidance issued in 1997.
“Almost from the enactment of the Medical Device Amendments to the Federal Food, Drug, 18 and Cosmetic Act (the FD&C Act) in 1976, the Food and Drug Administration (FDA or the 19 Agency) has attempted to define with greater clarity when a change in a medical device 20 would trigger the requirement that a manufacturer submit a new premarket notification 21 (510(k)) to the Agency.”
FDA recommends that manufacturers use the guidance’s flowcharts in concert with the guiding principles. The five flowcharts and corresponding text are intended to guide manufacturers through specific logic schemes, resulting in a clearer decision on whether to submit a new 510(k) for a change to an existing device. There is a flowchart for each main type of change — labeling, technology, engineering, performance, and material changes — as well as for technology, engineering, performance, and materials changes affecting in vitro diagnostic devices.
“Any guidance on 510(k)s for changes to a legally marketed device should consider the role 67 the Quality System (QS) regulation, 21 CFR Part 820, plays in changes to devices.”
“For some 68 types of changes to a device, the Agency believes that a new 510(k) is not necessary and that 69 reliance on existing QS requirements may reasonably assure the safety and effectiveness of 70 the changed device.”