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Will it require another person or additional resources to get the 21 CFR 820 classification?
sagai said:
there is no such thing
The FDA does provide a process for establishing the classification of novel, difficult-to-classify products. This however usually is applied to products that might be either Class II or III, with their manufacturers usually hoping to convince the FDA to consider them Class II.
In the case of a product that someone considers likely to be either Class I or II, usually a person with sufficient device regulatory experience will be able to determine a defensible classification based on precedent, i.e. your product will have the same classification as another company's earlier-introduced product to which it is sufficiently similar. Because there is so much history of prior products in the US device regulatory system, this is almost always straightforward.
If need be, your company might want to consider briefly hiring a consultant to determine, and provide you with memos-to-file justifying your stance on, these regulatory basics.
As mentioned earlier, a Class II product must have a 510(k) to be marketable. If your company in fact is the Manufacturer and will have to get the 510(k), I'd think you'd be likely to need some experienced help in preparing the submission. I don't know very many people who would enjoy the experience of preparing and interacting with FDA on a current-expectations 510(k) as their first regulatory task. It's a lot of work, and there are plenty of opportunities to make beginner-mistakes that result in a negative FDA initial review and way more work digging out of avoidable holes.