Question for discussion: Should a chosen predicate for a 510(k) be a device that has an active listing?
I don't see anything in any FDA guidances that requires this, but it seems like it might be prudent.
Consider a hypothetical device that has multiple 510(k)s over the years:
1. 2001: Original 510(k)
2. 2007: Update to include new indications
3. 2016: Update to incorporate new materials and technologies
Only the most recent iteration of the device (following the 2016 510(k)) is listed, and currently on the market.
However, what if my device is closer to the 2001 version? From my perspective it makes sense to select it as a predicate....but then I'm not really comparing it to what is "state of the art" for that device...
Discussion welcome.
I don't see anything in any FDA guidances that requires this, but it seems like it might be prudent.
Consider a hypothetical device that has multiple 510(k)s over the years:
1. 2001: Original 510(k)
2. 2007: Update to include new indications
3. 2016: Update to incorporate new materials and technologies
Only the most recent iteration of the device (following the 2016 510(k)) is listed, and currently on the market.
However, what if my device is closer to the 2001 version? From my perspective it makes sense to select it as a predicate....but then I'm not really comparing it to what is "state of the art" for that device...
Discussion welcome.