P
Hello,
We are working on a new med device at a startup. I currently am planning on filing the 510(k) AFTER I have all of the equipment in place, and would make the 510(k) submission a subset of my design verification testing (this is how we did it in a big med device company). However, now I am in startup mode and may need to re-sequence due to funding.
I am currently manufacturing all of my prototypes from third party vendors, whose processes will eventually be brought in-house. I believe I can maintain some level of control over their processes and should be able to obtain proper documentation. My question is can I file a 510k based upon product made by third party vendors, then re-perform design verification once all processes are transferred in house? Once transferred, are any additional filings required by the FDA?
Thanks,
potato124
We are working on a new med device at a startup. I currently am planning on filing the 510(k) AFTER I have all of the equipment in place, and would make the 510(k) submission a subset of my design verification testing (this is how we did it in a big med device company). However, now I am in startup mode and may need to re-sequence due to funding.
I am currently manufacturing all of my prototypes from third party vendors, whose processes will eventually be brought in-house. I believe I can maintain some level of control over their processes and should be able to obtain proper documentation. My question is can I file a 510k based upon product made by third party vendors, then re-perform design verification once all processes are transferred in house? Once transferred, are any additional filings required by the FDA?
Thanks,
potato124
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