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Hi there,
I come from a company manufacturing blood glucose monitoring system.
We outsourced a control solution developed by other company, and we apply for a 510(k) for it (using our trade name). That is, we actually did not manufacture control solution at the time.
Nevertheless, we are now going to manufacture the control solution by ourselves...
(1) Do we need to apply for a new 510(k)?
(2) What we should do in this kind of change in order to comply with QSR?
it's a little complicated...hope there is someone could help. Many thanks!
I come from a company manufacturing blood glucose monitoring system.
We outsourced a control solution developed by other company, and we apply for a 510(k) for it (using our trade name). That is, we actually did not manufacture control solution at the time.
Nevertheless, we are now going to manufacture the control solution by ourselves...
(1) Do we need to apply for a new 510(k)?
(2) What we should do in this kind of change in order to comply with QSR?
it's a little complicated...hope there is someone could help. Many thanks!