Do you have any tips/tricks for looking up device information on the FDA website? Sometimes the manufacturer is not the same as the company now marketing the device, sometimes the device name is not listed exactly the same way, etc.

We agree that the FDA website can be difficult to navigate, but don’t have any specific tips. In our experience, we typically request the 510(K) number or PMA number, company information, and device trade name. Additionally, many IRBs request documentation of the 510(k) clearance or PMA approval at initial review.