510k "Premarket" Submission for Existing Class II Software Medical Device

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.

keldez said:

What would you say are the appropriate initial steps...

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Coming clean?... Otherwise they'd have to continuously "hide" it and worry about what will happen when the FDA finds out.

I agree that carefully coming clean may be a good idea. Before you do that, it may be a good idea to make the analysis as to why the device was on the market, and for so long, before anyone realized it had to be cleared by FDA, and what you plan on doing while FDA reviews the 510(k). Internally, you may also want to figure out what you plan to do if you need to make changes in order to receive your clearance, and come up with a working rationale in case you need it.

And then prepare your premarket notification submission (your 510(k)).

just to add another penny to Sarah's two, once you make the assessment as to why the device was not cleared prior to marketing, prepare a response in case office of compliance contacts you before or during your submission.

Also, be careful about including real-world use data as part of your device validation. While it's good to show positive results (e.g. low defect rate, low complaint rate, no adverse events, etc.) from actual usage, you don't want to brag to the agency that your product was on the market.

In general, you have a much better chance of avoiding enforcement action when you take steps to comply than when you plead ignorance.