Voluntary Class I Device Filing
- Thread starter gogreen
- Start date
Watchcat
Trusted Information Resource
You can always register the device with FDA, but I think you are asking about a 510(k) type submission. I did a deep dive on this issue for a client last year, never came up with a firm answer.
I think you would have to submit a 510(k) and claim SE to another 510(k) exempt device. I had colleagues who said FDA would accept this and others who said it would not. Those who said yes pointed to examples that, upon closer inspection, were not what they seemed. Those who said no...can't prove a negative. What little information I could find from FDA was ambiguous, I thought.
So far, I have not come across anyone who wanted to front the cost of a 510(k) to find out. Maybe someone here has tried it.
Last year's client's situation was fairly unique, but there might have been another option for them, which they opted not to pursue. I don't feel comfortable getting into the specifics. However, if you want to tell me more about your device, there is a very small (I think) chance there might be another option for you. But, once again, I know of no one who has tried it, so I can't say for sure.
I think you would have to submit a 510(k) and claim SE to another 510(k) exempt device. I had colleagues who said FDA would accept this and others who said it would not. Those who said yes pointed to examples that, upon closer inspection, were not what they seemed. Those who said no...can't prove a negative. What little information I could find from FDA was ambiguous, I thought.
So far, I have not come across anyone who wanted to front the cost of a 510(k) to find out. Maybe someone here has tried it.
Last year's client's situation was fairly unique, but there might have been another option for them, which they opted not to pursue. I don't feel comfortable getting into the specifics. However, if you want to tell me more about your device, there is a very small (I think) chance there might be another option for you. But, once again, I know of no one who has tried it, so I can't say for sure.
Watchcat
Trusted Information Resource
The other option requires your device to be usable as a component of a system that includes at least one 510(k) device as another component of the system. So not likely to work for you.
If your original question was really whether there is another type of submission that is cheaper and easier than a 510(k), the answer is no. The only submission that might possibly work is a 510(k), and the tricky part is whether FDA would even review a 510(k) claiming SE to a 510(k)-exempt predicate.
If your company is willing to pay the costs associated with preparing and submitting a 510(k), if it feels confident FDA will clear it, then, really, the simplest thing to do would be to email the head of the appropriate reviewing group and ask if they would accept a 510(k) claiming a 510(k)-exempt device as the predicate. On the one hand, it doesn't seem to make sense for FDA to spend resources reviewing a 510(k) that isn't needed from a regulatory perspective. On the other, it's a low-risk device so should be fairly easy to review, if the 510(k) is put together properly. In that case, who knows, they might accept it just to get the filing fee. I was not able to find anything that said FDA could not do this if it wanted to.
If your original question was really whether there is another type of submission that is cheaper and easier than a 510(k), the answer is no. The only submission that might possibly work is a 510(k), and the tricky part is whether FDA would even review a 510(k) claiming SE to a 510(k)-exempt predicate.
If your company is willing to pay the costs associated with preparing and submitting a 510(k), if it feels confident FDA will clear it, then, really, the simplest thing to do would be to email the head of the appropriate reviewing group and ask if they would accept a 510(k) claiming a 510(k)-exempt device as the predicate. On the one hand, it doesn't seem to make sense for FDA to spend resources reviewing a 510(k) that isn't needed from a regulatory perspective. On the other, it's a low-risk device so should be fairly easy to review, if the 510(k) is put together properly. In that case, who knows, they might accept it just to get the filing fee. I was not able to find anything that said FDA could not do this if it wanted to.