Is it acceptable it is to list new products under an existing 510(k)?

[image182]

Perhaps a basic question, but i'm just wondering about how acceptable it is to list new products under an existing 510(k).

Using the change to a 510(k) flowcharts they changes either result in a new 510(k) or an internally documented note to file.

For instance we could get clearance for device (A) under a 510(k) and then document a change such as a change in sterilisation, performance specification, dimensional specification etc... therefore creating an updated device (A2)

However, is it acceptable (common practice) to go through the same process but keep the original device (A) but then list the updated device as a new product i.e. device (B).

Using this method you could submit a 510(k) for one device. But through the documentation, note to file process you could end up with a large number of slightly different devices listed under this 510(k) with different packaging, dimensions, sterilisation methods etc....

Thanks

 

[Ronen E]

Perhaps a basic question, but i'm just wondering about how acceptable it is to list new products under an existing 510(k).

Using the change to a 510(k) flowcharts they changes either result in a new 510(k) or an internally documented note to file.

For instance we could get clearance for device (A) under a 510(k) and then document a change such as a change in sterilisation, performance specification, dimensional specification etc... therefore creating an updated device (A2)

However, is it acceptable (common practice) to go through the same process but keep the original device (A) but then list the updated device as a new product i.e. device (B).

Using this method you could submit a 510(k) for one device. But through the documentation, note to file process you could end up with a large number of slightly different devices listed under this 510(k) with different packaging, dimensions, sterilisation methods etc....

Thanks

Hi,

If the flowchart shows that the change warrants a new 510(k) then you will have to get such a new special 510(k) (device modification) cleared, then list under that newly cleared 510(k). Otherwise issue a note-to-file and list under the existing 510(k).

I hope I understood your question correctly, not sure though...

Cheers,
Ronen.

 

[image182]

Hi Ronen,

It's more that I'm unsure if the note to file process can be used to used to do two separate things when making modifications to a cleared device.
1) Device "A" is modified to make device "A2". Only the modified device "A2" is listed and sold.
2) Device "A" is modified to make device "B", "C", "D" and "E". Then the 4 new devices are also listed and sold in addition to the original device "A".

 

[Ronen E]

Hi Ronen,

It's more that I'm unsure if the note to file process can be used to used to do two separate things when making modifications to a cleared device.
1) Device "A" is modified to make device "A2". Only the modified device "A2" is listed and sold.
2) Device "A" is modified to make device "B", "C", "D" and "E". Then the 4 new devices are also listed and sold in addition to the original device "A".

It doesn't really matter if A is being sold or not.

If either B, C, D or E are similar enough to each other and require a new 510(k), they might be cleared under a single submission (and consequently listed under the same 510(k)).

I hope that the above gets you a little closer to enlightenment... I'm still not sure I understand your query.

Cheers,
Ronen.

 

[MIREGMGR]

FDA explicitly says no, not allowed. A 510(k) cleared for a single product can only ever cover a single product.

This however has long been common practice, particularly with quite old 510(k)s for which there's no practical way to prepare a supplemental submission because the original submission was made under much less comprehensive guidelines. The wiggle room is that FDA does not define any timing for when a 510(k) covers a given device, and when its coverage switches to a (flowchart permissible) second device. So, you make some device A and some device B, both nominally covered by the same single-device 510(k). When Customer C calls and wants to buy device A, that's the one that you're marketing at that moment, so that's the one the 510(k) covers. When Customer D calls 5 minutes later and wants to buy device B, that's now the one that the 510(k) covers.

Obviously this is sophistry, but that's the common argument.

It of course is possible to clear a 510(k) for a family of similar products, and later (possibly) add more products within the bounds of the family definition. That however is not the scenario you asked about.

Make of that what you will. If you are caught, you certainly won't be able to cite other companies as precedent.

 

[image182]

Thanks for the response MIREGMGR, that's what I thought...

FDA explicitly says no, not allowed. A 510(k) cleared for a single product can only ever cover a single product.

Could you perhaps point me towards where you found the above information? Is it detailed in the CFR? I would like to read further into it as i've never found anything which said you either can or can't do it.

Sorry if it's a basic question, i'm fairly new to the field.

Thanks again

 

[Ronen E]

It of course is possible to clear a 510(k) for a family of similar products, and later (possibly) add more products within the bounds of the family definition. That however is not the scenario you asked about.

This is what I was referring to. I didn't mention "family" because in my experience the original 510(k) doesn't have to spell it out or be especially constructed upfront to accommodate more family members in the future; if the new member is close enough to the original device then they become de-facto "a device family" and benefit (both) the existing clearance.

This is all very theoretical and linguistic. "A new device version", "a device family member", "a modification to an existing device" and "a new device" are all very elusive and relative. The situation should eventually be judged based on the specifics.

 

[MIREGMGR]

Could you perhaps point me towards where you found the above information? Is it detailed in the CFR? I would like to read further into it as i've never found anything which said you either can or can't do it.

Sorry if it's a basic question, i'm fairly new to the field.

Consult the various 510(k) related guidances. FDA's language is significant; when they write "device" (singular), that's what they mean. FDA's stance consistently has been one device, one submission. For a definitive explanation of the exceptions to that practice, see the guidance "Bundling Multiple Devices or Multiple Indications in a Single Submission", 22JUN2007.

 

[image182]

Hi all,

Thanks for the help so far. I guess it seems like there are two contradictory trains of thought....

If a singular device was cleared under a 510(k), then:

(Ronen) Additional devices can be added to the 510(k) through the note-to-file process to create a "device family"

or

(MIREGMGR) No additional devices can be added as the 510(k) was cleared for one device only. If multiple devices are to be listed under a single 510(k) then a new 510(k) must be made where multiple devices are bundled into a single 510(k) submission.

 

[Ronen E]

(Ronen) Additional devices can be added to the 510(k) through the note-to-file process to create a "device family"

Only if the flowchart shows that a new 510(k) is not required.