Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

We are planning on adding a new contract manufacturer (duplication) in addition to our existing one. If there are no process changes or even minimal process changes (all of which are an LTF), and the manufacturer is ISO 13485 certified. What are you thoughts on if adding a new contract manufacturer is significant enough to trigger a new 510(k)?

I'm pretty torn and feel like it is and is not significant - but curious to hear other people's thoughts. Also, if this is significant, has anyone done a change like this through a special 510(k) before?

Thank you.

Hello Anon,

There has been other posts like this asked and in most cases a new 510(k) submission would not be required.  If you refer back to the FDA's guidance document on determining changes to a 510(k), changes in supplier would usually not require a new 510(k) submission.  As you indicate as long as the process is the same which would not impact the safety and efficacy of the device, then a letter to file could be made.  All of this would be supported by any change notification, equipment validations, or process validations which might be needed for the change to new contract manufacturer.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-May-2022 11:46
From: Anonymous Member
Subject: Adding Contract Manufacturer Trigger new 510(k)?

This message was posted by a user wishing to remain anonymous

Hi All,

We are planning on adding a new contract manufacturer (duplication) in addition to our existing one. If there are no process changes or even minimal process changes (all of which are an LTF), and the manufacturer is ISO 13485 certified. What are you thoughts on if adding a new contract manufacturer is significant enough to trigger a new 510(k)?

I'm pretty torn and feel like it is and is not significant - but curious to hear other people's thoughts. Also, if this is significant, has anyone done a change like this through a special 510(k) before?

Thank you.

This message was posted by a user wishing to remain anonymous

Good morning Anon, Richard is right but I'll add one exception I'm aware of. We 3D print ortho implants, and FDA expects a traditional 510(k) when adding a 3DP subcontractor. This is not in any guidance doc, but is enforced anyway based on their need to understand process variation and its effect on device performance
Original Message:
Sent: 13-May-2022 11:46
From: Anonymous Member
Subject: Adding Contract Manufacturer Trigger new 510(k)?

This message was posted by a user wishing to remain anonymous

Hi All,

We are planning on adding a new contract manufacturer (duplication) in addition to our existing one. If there are no process changes or even minimal process changes (all of which are an LTF), and the manufacturer is ISO 13485 certified. What are you thoughts on if adding a new contract manufacturer is significant enough to trigger a new 510(k)?

I'm pretty torn and feel like it is and is not significant - but curious to hear other people's thoughts. Also, if this is significant, has anyone done a change like this through a special 510(k) before?

Thank you.