Tag: 510(k)

One option to get more information about what the FDA may be looking for is to check the 510k database for similar devices that have been subjected to a Freedom of Information request, or FOIA Request.

Looking at the classification order or the reclassification order for device types can give you a lot of insight into the FDA’s thoughts on the benefit risk argument for your device. Addressing the FDA identified risks using the special controls identified for each risk correctly can boost your 510k clearance chances.