Hello,
I am sending myself a little mad going round in circles here.
So.......we have come up against what I fear is a common issue; our contract manufacturers have decided that they fear the FDA too much and they don't wish to be listed with them anymore. They supply us with a class II device that has had 510K clearance for over two years but are yet to be audited.
The current contract manufacturer is happy to supply all of the components, so we would only need them finished, packaged and sterilised with new manufacturer (who is already listed with the FDA and has been audited many times).
I have three questions:
1) Am I right in thinking that in order to implement this change we would need to run new biocompatibility AND performance testing AND to submit a new 510K with the 'new device'?
2) We are concerned that there will now be a break in the supply chain whilst waiting for the above mentioned testing and 510K clearance; can our US distributor buy extra stock from us prior to the changes which can then be sold after the end of this year (if necessary) and before the new device has gained clearance? So our current contract manufacturer would not renew their listing for this next year but the device would have been manufactured whilst they were listed. Can the US distributor then sell the device in say January while we wait for the new product to gain clearance?
3) Have I mis-read the guidance and in fact we won't need a new 510K submission as the components of the device have remained the same?
Many thanks for taking the time to read this.
Katie
I am sending myself a little mad going round in circles here.
So.......we have come up against what I fear is a common issue; our contract manufacturers have decided that they fear the FDA too much and they don't wish to be listed with them anymore. They supply us with a class II device that has had 510K clearance for over two years but are yet to be audited.
The current contract manufacturer is happy to supply all of the components, so we would only need them finished, packaged and sterilised with new manufacturer (who is already listed with the FDA and has been audited many times).
I have three questions:
1) Am I right in thinking that in order to implement this change we would need to run new biocompatibility AND performance testing AND to submit a new 510K with the 'new device'?
2) We are concerned that there will now be a break in the supply chain whilst waiting for the above mentioned testing and 510K clearance; can our US distributor buy extra stock from us prior to the changes which can then be sold after the end of this year (if necessary) and before the new device has gained clearance? So our current contract manufacturer would not renew their listing for this next year but the device would have been manufactured whilst they were listed. Can the US distributor then sell the device in say January while we wait for the new product to gain clearance?
3) Have I mis-read the guidance and in fact we won't need a new 510K submission as the components of the device have remained the same?
Many thanks for taking the time to read this.
