Softgoods Grading Advice/Insight

I know 510K clearances are on the FDA website and they provide a little of the information a company must give. I don’t know if you can see the application itself, I doubt it, but I’m not in regulatory and don’t need to research it. Thank god.

But if your device is 510K exempt, you won’t find anything similar as there is nothing to submit.

But class 1 is usually 510K exempt. I’d worry much more about being GMP exempt. If you aren’t, kiss your May launch goodbye.