Medical Device 510 (k)
If your are manufacturing hematology controls and file a 510(k) and decide to move to another location. Do you have to re-file a new 510(k) for the new location.
Al |Founder and Consultant
No, you do not need to file a new 510(k). The 510(k) is a marketing clearance and does not involve ...13.6 Hours Later
George |Prinicipal Quality Consultant
No, 510k not required, but compliance to QSR / 21CFR820 is required and in relocation of a process r...2.1 Days Later
No a 510(k) will not be required. I would recommend investigating the re-validation of all your ma...42.8 Days Later