Let's say, hypothetically, that I have a possible client that's had a Class II software device on the market for 5+ years without any 510k/FDA knowledge. What would you say are the appropriate initial steps to get this product in compliance in terms of 510k/registering company and device?
Would a Premarket Submission still be the most advised initial step, and from that point navigate FDA response?
FYI/FWIW, the device is extremely low risk.
Would a Premarket Submission still be the most advised initial step, and from that point navigate FDA response?
FYI/FWIW, the device is extremely low risk.