is it possible for a company to submit 2 different 510k for the same medical device under the same brand name?
If yes then how is the design traceability guarantied
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.....
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?
Are my thoughts correct or am I missing something?
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.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.
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!!