Will We See Changes In FDA 510(k) Process for Medical Devices?

Good question. I wish I knew the answer. Every week, there are numerous posts and articles suggesting that the FDA 510(k) process may be overhauled in the not too distant future. For those not familiar, a 510(k) is a submission to FDA in order to receive market clearance for the majority of class II medical devices (and some class III). The current process requires the submitter to demonstrate “substantial equivalence” to a previously cleared device.

The recent press and news has called for a new and improved process to clear class II devices through FDA. Those calling for the changes have suggested the current process is too lax and that more controls should be implemented.

Of course it’s too soon to know exactly what this means to the medical device industry. However, it’s probably safe to assume that receiving market clearance from FDA will definitely become more difficult and not simpler.

You can read more about a recent meeting FDA held with industry on the 510(k) process.