Hello All,
Please bear with me as i'm slowly learning the complex ropes of US FDA QSR on medical devices.
I appreciate your patience in reading this post and any insights that you can provide will be greatly appreciated. Thank you for your time.
Please bear with me as i'm slowly learning the complex ropes of US FDA QSR on medical devices.
- We are a US medical device company (ABC company) and are listed with the FDA as the "manufacturer".
- We have a 510(k) on our class II medical device and traditionally have a "critical supplier" in china (who is ISO 13485:2016 certified and who we have a quality agreement with) make our device, which is then shipped to our facility in the US and subjected to quality testing etc. before finally being assembled into a box with accessories and DFU/IFU.
- In this traditional relationship we are listed on the box as the manufacturer and the FDA has been happy with it in our last two audits.
- We are now in discussions with a third party (XYZ company) in the US who is interested in marketing our device. To meet initial volume, we are interested in ideally having our critical supplier in china finish the assembly portions of the device as well and ship the packaged device directly to the distributor in the US. My questions to the peers in this forum are as follows:
- Who can/should be listed as the manufacturer on the box?
- Since the FDA allows either the distributor or manufacturer to be listed on the box, is it possible to list XYZ company as the distributor on the box? If not, can ABC company be listed as the distributor?
- Can ABC company still be considered a "manufacturer" by the FDA definition since we own the 510(k) and develop the specifications/conduct R&D?
- If the critical supplier in china starts to package the device, do they have to be registered with the FDA as a manufacturer instead of being identified as a critical supplier in our QMS?
I appreciate your patience in reading this post and any insights that you can provide will be greatly appreciated. Thank you for your time.