Hello,
Depending on the lead time to commission a new facility this should not be an insurmountable problem. I would definitely recommend speaking with FDA soon though (I don't normally care for pre-sub meetings but this is a case where one would be wise). How difficult it will be to change facilities depends largely on what you've already communicated to the Agency regarding the CMC requirements for manufacturing the device. If it's a blank slate then you may only need to consider ensuring that the new facility meets or exceeds the CMC controls in place during Clinical Manufacturing of your test articles. CDRH and CDER are usually very cooperative about relocating manufacturing processes (CBER, not so much), so ask them what their specific concerns are and then fully address them (and all should work out).
I hope this helps.
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Steven Appel RAC
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Original Message:
Sent: 08-Jan-2018 14:15
From: Devang Barot
Subject: PMA Strategy
Hi Folks,
I am working for a medical Device company. We manufacture Class III Product. My Company manufactures a Class III medical device that is currently under an IDE clinical trial in the US. The company has outgrown its current location and wishes to close its current manufacturing facility and move all manufacturing operations to a nearby city. Due to OUS demand, the business cannot wait to expand until after PMA approval (~2 years). What would be a reference to available regulations and guidance documents, and regulatory strategy for the US. Will it have any impact of this change to both the IDE as well as the forthcoming PMA?
Thanks,
Much appreciated,
Regards,