Regulatory Open Forum

Hello everyone,

I am fairly new to the RA Manager role and just getting really confused with the 510(k) process (although it might be fairly easy). I was wondering if I can get some answers/clarifications please.

We have a medical device that we want 510(k) clearance for. I have gone through the process of classifying the device as Class II and identified the product Panel, Product Code and CFR regulation number. I have also filtered few different predicate products to start with, based on the intended use. We will apply for 510(k) clearance for that. Now once we get the 510(k) clearance from FDA, we would like to add another intended use that is totally different from the initial one. Is it acceptable to apply for a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.

Could I please get some clarification as I am quite confuse. Thanks a lot in advance.

Dear Harsha,

Yes, it is most definitely acceptable to have a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.  In fact, that will require a separate 510(k).  However, you may submit the two 510(k)'s concurrently if so desired.  In other words, there is no need (from an FDA statutory/regulatory perspective) for either 510(k) to be contingent on the other.

Hello everyone,

I am fairly new to the RA Manager role and just getting really confused with the 510(k) process (although it might be fairly easy). I was wondering if I can get some answers/clarifications please.

We have a medical device that we want 510(k) clearance for. I have gone through the process of classifying the device as Class II and identified the product Panel, Product Code and CFR regulation number. I have also filtered few different predicate products to start with, based on the intended use. We will apply for 510(k) clearance for that. Now once we get the 510(k) clearance from FDA, we would like to add another intended use that is totally different from the initial one. Is it acceptable to apply for a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.

Could I please get some clarification as I am quite confuse. Thanks a lot in advance.

Thanks a lot for the clarification Dan. One more question if you wouldn't mind please, say once we get the initial 510(k) approved and we want to apply for the second intended use (which is totally different from initial product panel and code). I read somewhere that I can use my own product as a predicate. If I choose to use my own device as the predicate device, would it be acceptable as our product would still be class II but would be most likely reviewed by a different panel (as there will be different intended use) or will we have to select a different predicate product that will have the same intended use as the ones we would want to add. The reason I am getting confused is because some of the CDRH webinars said that the intended use of the device should be same as predicate device. Or, would this not apply as it will be our own product with a totally diffrerent set of additional intended use- which I don't think is possible/acceptable. I understand that we won't be able to apply for special 510(k) and will have to go with Traditional one only ( as the intended use will change) but just confused about if and how can we use our own device as the predicate product for additional intended use.

Dear Harsha,

Yes, it is most definitely acceptable to have a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.  In fact, that will require a separate 510(k).  However, you may submit the two 510(k)'s concurrently if so desired.  In other words, there is no need (from an FDA statutory/regulatory perspective) for either 510(k) to be contingent on the other.

Hello everyone,

I am fairly new to the RA Manager role and just getting really confused with the 510(k) process (although it might be fairly easy). I was wondering if I can get some answers/clarifications please.

We have a medical device that we want 510(k) clearance for. I have gone through the process of classifying the device as Class II and identified the product Panel, Product Code and CFR regulation number. I have also filtered few different predicate products to start with, based on the intended use. We will apply for 510(k) clearance for that. Now once we get the 510(k) clearance from FDA, we would like to add another intended use that is totally different from the initial one. Is it acceptable to apply for a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.

Could I please get some clarification as I am quite confuse. Thanks a lot in advance.

Thanks a lot for the clarification Dan. One more question if you wouldn't mind please, say once we get the initial 510(k) approved and we want to apply for the second intended use (which is totally different from initial product panel and code). I read somewhere that I can use my own product as a predicate. If I choose to use my own device as the predicate device, would it be acceptable as our product would still be class II but would be most likely reviewed by a different panel (as there will be different intended use) or will we have to select a different predicate product that will have the same intended use as the ones we would want to add. The reason I am getting confused is because some of the CDRH webinars said that the intended use of the device should be same as predicate device. Or, would this not apply as it will be our own product with a totally diffrerent set of additional intended use- which I don't think is possible/acceptable. I understand that we won't be able to apply for special 510(k) and will have to go with Traditional one only ( as the intended use will change) but just confused about if and how can we use our own device as the predicate product for additional intended use.

Dear Harsha,

Yes, it is most definitely acceptable to have a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.  In fact, that will require a separate 510(k).  However, you may submit the two 510(k)'s concurrently if so desired.  In other words, there is no need (from an FDA statutory/regulatory perspective) for either 510(k) to be contingent on the other.

Hello everyone,

I am fairly new to the RA Manager role and just getting really confused with the 510(k) process (although it might be fairly easy). I was wondering if I can get some answers/clarifications please.

We have a medical device that we want 510(k) clearance for. I have gone through the process of classifying the device as Class II and identified the product Panel, Product Code and CFR regulation number. I have also filtered few different predicate products to start with, based on the intended use. We will apply for 510(k) clearance for that. Now once we get the 510(k) clearance from FDA, we would like to add another intended use that is totally different from the initial one. Is it acceptable to apply for a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.

Could I please get some clarification as I am quite confuse. Thanks a lot in advance.

Thanks a lot for the clarification Dan. One more question if you wouldn't mind please, say once we get the initial 510(k) approved and we want to apply for the second intended use (which is totally different from initial product panel and code). I read somewhere that I can use my own product as a predicate. If I choose to use my own device as the predicate device, would it be acceptable as our product would still be class II but would be most likely reviewed by a different panel (as there will be different intended use) or will we have to select a different predicate product that will have the same intended use as the ones we would want to add. The reason I am getting confused is because some of the CDRH webinars said that the intended use of the device should be same as predicate device. Or, would this not apply as it will be our own product with a totally diffrerent set of additional intended use- which I don't think is possible/acceptable. I understand that we won't be able to apply for special 510(k) and will have to go with Traditional one only ( as the intended use will change) but just confused about if and how can we use our own device as the predicate product for additional intended use.

Dear Harsha,

Yes, it is most definitely acceptable to have a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.  In fact, that will require a separate 510(k).  However, you may submit the two 510(k)'s concurrently if so desired.  In other words, there is no need (from an FDA statutory/regulatory perspective) for either 510(k) to be contingent on the other.

Hello everyone,

I am fairly new to the RA Manager role and just getting really confused with the 510(k) process (although it might be fairly easy). I was wondering if I can get some answers/clarifications please.

We have a medical device that we want 510(k) clearance for. I have gone through the process of classifying the device as Class II and identified the product Panel, Product Code and CFR regulation number. I have also filtered few different predicate products to start with, based on the intended use. We will apply for 510(k) clearance for that. Now once we get the 510(k) clearance from FDA, we would like to add another intended use that is totally different from the initial one. Is it acceptable to apply for a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.

Could I please get some clarification as I am quite confuse. Thanks a lot in advance.

Hello everyone,

I am fairly new to the RA Manager role and just getting really confused with the 510(k) process (although it might be fairly easy). I was wondering if I can get some answers/clarifications please.

We have a medical device that we want 510(k) clearance for. I have gone through the process of classifying the device as Class II and identified the product Panel, Product Code and CFR regulation number. I have also filtered few different predicate products to start with, based on the intended use. We will apply for 510(k) clearance for that. Now once we get the 510(k) clearance from FDA, we would like to add another intended use that is totally different from the initial one. Is it acceptable to apply for a second 510(k) for the same device with an entirely different set of product Panel, Product Code and CFR regulation number with a new predicate product in that category.

Could I please get some clarification as I am quite confuse. Thanks a lot in advance.

Hi All,

Thanks a lot for all the information. It has really helped me clarify the process. I am thinking the best bet would be to use a different predicate product rather than our own. Another question though, and I am sure the answer is "No, its not possible and I will need two different 510(k)s" but just want a confirmation.

So, if I want two different intended use (that will be under a totally different review panel and regulation number with different product code), will I most definitely have to apply for two different 510(k)'s? I can't really have two predicate products on the same application with two different set of intended use and product panel, code and regulation number, right?

I really appreciate all of your replying back as it is really helping me out with this new role. Thanks a lot.

Do you want the device to have both intended uses? Or two separate products, each with its own intended use?

You may want to check out the section on multiple predicates and reference devices in the Substantia; Equivalence guidance that came out in 2014, as well as the part on Intended Use and changes to Indications for Use that comes right after it as they have some good examples:

http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf#page=14

Hi All,

Thanks a lot for all the information. It has really helped me clarify the process. I am thinking the best bet would be to use a different predicate product rather than our own. Another question though, and I am sure the answer is "No, its not possible and I will need two different 510(k)s" but just want a confirmation.

So, if I want two different intended use (that will be under a totally different review panel and regulation number with different product code), will I most definitely have to apply for two different 510(k)'s? I can't really have two predicate products on the same application with two different set of intended use and product panel, code and regulation number, right?

I really appreciate all of your replying back as it is really helping me out with this new role. Thanks a lot.