The 510(k) program is the most common pathway through which medical devices make their way to market in the US.
For devices that can demonstrate “substantial equivalence” to a device that is already on the market, this premarket submission to the US Food and Drug Administration (FDA) is a necessary step to market the device in the US. But that doesn’t make the 501(k) program a simple subject.
RAPS spoke with Mark DuVal, a RAPS member who serves as the president and CEO of DuVal & Associates, about the 510(k) program, the common difficulties and misconceptions regulatory professionals have with it, his upcoming RAPS workshop on the subject and more. This conversation has been lightly edited for clarity…
