Two separate 510k submissions for one device from the same company
Curious why you're asking? Do you plan to try? Are two exactly the same?
Not completely sure what you mean by "design traceability", but generally speaking product design, and unit traceability should be integrated into your quality system. This is independent of FDA 510(k)s.
With respect to the FDA, if the devices are different, they would have different device identifiers, and different device listings. ..but you are saying they are the same? Again, are they exactly the same?
I'm also curious as to the circumstances inviting such action.
regarding "design traceability" I think what the OP meant was "how would the FDA know to which of the submissions/clearances a given physical device, on the market, belongs?"
Following the same line of thought, I think that the FDA's primary/unambiguous identifier for a device in the 510(k) system is its brand name. If I'm correct then it shouldn't be possible to clear two submissions with the exact same brand name, at least not by the same manufacturer. I think that if the same physical device has two different uses that are submitted separately under two different 510(k)s, the FDA would expect at least some small difference in their designations, eg Widget vs. Widget-X.
regarding "design traceability" I think what the OP meant was "how would the FDA know to which of the submissions/clearances a given physical device, on the market, belongs?"
Following the same line of thought, I think that the FDA's primary/unambiguous identifier for a device in the 510(k) system is its brand name. If I'm correct then it shouldn't be possible to clear two submissions with the exact same brand name, at least not by the same manufacturer. I think that if the same physical device has two different uses that are submitted separately under two different 510(k)s, the FDA would expect at least some small difference in their designations, eg Widget vs. Widget-X.
P
PASO_ADEIL
Thank you both very much! By design traceability, I meen design change control. Because if a company has cleared the same device (exactly the same device) two times (2x 510k) how and in which DHF will the changes be classified?
Because if a company has two 510k for the exact same design she must also have 2 DHF...
Thank you
Because if a company has two 510k for the exact same design she must also have 2 DHF...
Thank you
P
PASO_ADEIL
Well this is a very tricky situation…
The company that I am working for has an organizational structure that at the moment doesn’t cover the “manufacturer – contract manufacturer” demands.
There is a development department and manufacturing facility in Europe that also owns the design (DHF) of this medical device. The existing 510k was issued initially only for this facility. Latter on the company acquired also a facility in the US and they decided (without consulting the RA department) to change the ownership of this 510k and register both facilities as manufacturer and contract manufacturer simultaneously. So, there seems to be two manufacturers/contract manufacturers under the same. How can that even be possible?
The management (again without consulting the RA department) thought that two 510k might be the solution in this case.
If you ask me this would be time and money lose plus it will create internal completion.
Plus there is also the design change control. Which changes are to which 510k classified and of course as the colleague RONEN E mentioned, how would the FDA know to which of the submissions/clearances a given physical device, on the market, belongs?
Are my thoughts correct or am I missing something?
The company that I am working for has an organizational structure that at the moment doesn’t cover the “manufacturer – contract manufacturer” demands.
There is a development department and manufacturing facility in Europe that also owns the design (DHF) of this medical device. The existing 510k was issued initially only for this facility. Latter on the company acquired also a facility in the US and they decided (without consulting the RA department) to change the ownership of this 510k and register both facilities as manufacturer and contract manufacturer simultaneously. So, there seems to be two manufacturers/contract manufacturers under the same. How can that even be possible?
The management (again without consulting the RA department) thought that two 510k might be the solution in this case.
If you ask me this would be time and money lose plus it will create internal completion.
Plus there is also the design change control. Which changes are to which 510k classified and of course as the colleague RONEN E mentioned, how would the FDA know to which of the submissions/clearances a given physical device, on the market, belongs?
Are my thoughts correct or am I missing something?
JeantheBigone
Quite Involved in Discussions
That DOES sound like a tricky situation.
I can't see the benefit in submitting two identical 510(k)s for the exact same device with the exact same indications for use from the same manufacturer. I would also think that the FDA reviewer might even question it when they receive it, since the same panel (if not the same lead reviewer) would have to review it.
It is entirely possible for different locations to have different functions and be registered, ie "ACME Medical Devices Corp USA" "ACME Medical Devices Ltd Europe."
Changing the registration and listing information is a relatively simple matter. I may not have all the details, but it seems to me that the more logical solution would be to have the 510(k)-holder be listed as the manufacturer, this is where the DHF would reside. The other facility would be a contract manufacturer for that device, and register and list using the existing 510(k).
I can't see the benefit in submitting two identical 510(k)s for the exact same device with the exact same indications for use from the same manufacturer. I would also think that the FDA reviewer might even question it when they receive it, since the same panel (if not the same lead reviewer) would have to review it.
It is entirely possible for different locations to have different functions and be registered, ie "ACME Medical Devices Corp USA" "ACME Medical Devices Ltd Europe."
Changing the registration and listing information is a relatively simple matter. I may not have all the details, but it seems to me that the more logical solution would be to have the 510(k)-holder be listed as the manufacturer, this is where the DHF would reside. The other facility would be a contract manufacturer for that device, and register and list using the existing 510(k).
Michael Malis
Quite Involved in Discussions
Hi Paso,
First, 510(k) does not belong to facility - it is belong to the company.
Therefore, company has the right to produce this product in any facility as long as product is validated and facility and product is registered appropriately.
Second, what you need is to update your technical file (TF) to show both facilities for thew same product. Assuming that new facility and product is validated and documented correctly, you have to:
1. Update facility registration
2. Notify your registrar and add this product to CE Cert.
After that you will have the same product manufactured in 2 (or more) facilities, but the product label will reflect the appropriate (one) facility address. You will need this for product traceability.
Regards,
Michael
U
uhohraggy
What Michael said!
If you submit a second 510(k) for the same device the FDA will likely throw it back at you (I've seen this happen...well not literally, but they came back and asked what in the heck we were doing). The TF is for the EU, so that's if your product is marketed there.
If you submit a second 510(k) for the same device the FDA will likely throw it back at you (I've seen this happen...well not literally, but they came back and asked what in the heck we were doing). The TF is for the EU, so that's if your product is marketed there.
EyesWideOpen
Registered
I have a question about this exact situation. The management in my company wants to submit another 510(k) in month for the product that is currently in 510(k) review. The change will change the indications.
I'm trying to tell them why this makes no sense logically, but they need something more firm to grasp. I also believed that the FDA would simply send back a 510(k) submission for a product already undergoing 510(k) review. Are you aware of any specific FDA guidance or other official word on having only one 510(k) in review at a time?
To me it's obvious that if the indications of the original predicate change while in review then what you're claiming equivalence to is no longer a valid predicate, but getting this through to the clueless masses of middle management is nearly impossible and they're too impatient to wait for one to get cleared before submitting the next.
Thanks!!
QAengineer13
Quite Involved in Discussions
Based on what you mentioned in your previous comment , it looks like FDA can use their Refuse to Accept Policy for 510(k) for the first submission based on the changes in the intended use in your second 510k.
""To find a device substantially equivalent under section 513(i) of the FD&C Act, FDA must find that it has the same intended use as the predicate device, and either (1) has the same technological characteristics as the predicate device, or (2) has different technological characteristics, as defined at section
513(i)(1)(B), and the submission contains information, including appropriate clinical or scientific data if necessary, that demonstrates the device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness than the predicate.""
Source: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf
""To find a device substantially equivalent under section 513(i) of the FD&C Act, FDA must find that it has the same intended use as the predicate device, and either (1) has the same technological characteristics as the predicate device, or (2) has different technological characteristics, as defined at section
513(i)(1)(B), and the submission contains information, including appropriate clinical or scientific data if necessary, that demonstrates the device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness than the predicate.""
Source: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf