Day: September 24, 2024

Make a killer 510k part 1
Haylee Bosshard

Make a killer 510(k) – Part 1

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.

Read More »