Hi Devang,
As you know, defining the regulatory strategy for a Medical Device is a huge task and will require lot of inputs from different areas to come up with a proper strategy. I would just like to add my inputs for your regarding IDE and PMA changes.
Regarding IDE, I assume that your medical device is already under clinical investigation and if the manufacturing facility will be changed to the new facility, you will have to submit a IDE supplement to FDA describing the manufacturing process changes and if there are any design changes. This will require FDA's approval as this is a major change.
Since you are under clinical investigation, I believe PMA would not have been submitted and hence when you submit your PMA you can include the information about the manufacturing facility. Please note if a PMA was already submitted then we will need a PMA supplement to describe the manufacturing changes.
I hope this helps you to begin with your strategy and please feel free to let me know if you are looking for any guidance documents on this.
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Loganathan Kumarasamy
Senior Consultant,
Zifo RnD Solutions,
United States
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Original Message:
Sent: 10-Jan-2018 09:24
From: Devang Barot
Subject: PMA Strategy
Hi Folks,
I am working for a class III product and I have to make regulatory Strategy for U.S and EU. Here is my scenario:
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). Making reference to available regulations and guidance documents, please detail the regulatory strategy for the US. What will be the change to both the IDE as well as the forthcoming PMA?
What will be EU strategy for the same scenario?
Any help is appreciated,
Thanks in advance,
Kind Regards,
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Devang Barot
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