Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Greetings !!

I am wondering the process to evaluate the impact of material change for a class II device in the US from one type of HDPE to another HDPE. Going from one HDPE to another HDPE can be considered as a substantial change or not assuming the manufacturer has not used the new type of HDPE before. Thoughts?

To evaluate the impact of a material change for a US class II device, first remember that such a change is a design change needing appropriate processing per the design control subsystem [specifically, 21 CFR 820.30(i)]. Secondly, be sure to apply the deliberations in FDA's October 2017 guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device", which contains a section (e.g., Flowchart C and supporting narratives therein) specifically dedicated to assessing material changes.

Hope this helps,

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 10-Nov-2020 19:53
From: Anonymous Member
Subject: Material Change

This message was posted by a user wishing to remain anonymous

Greetings !!

I am wondering the process to evaluate the impact of material change for a class II device in the US from one type of HDPE to another HDPE. Going from one HDPE to another HDPE can be considered as a substantial change or not assuming the manufacturer has not used the new type of HDPE before. Thoughts?

Hi Anon,

I'm with Kevin on that. Change of materials is considered a design change.
You have to check again the design outputs if they still conform with your system. If you can prove that the safety and performance are still the same, then i believe you will be ok. I think you will need to introduce some verification activities in your risk management system to prove the significance of the material change.

I do not know your device, but HDPE is a common material and I think it will be an easy task

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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 10-Nov-2020 19:53
From: Anonymous Member
Subject: Material Change

This message was posted by a user wishing to remain anonymous

Greetings !!

I am wondering the process to evaluate the impact of material change for a class II device in the US from one type of HDPE to another HDPE. Going from one HDPE to another HDPE can be considered as a substantial change or not assuming the manufacturer has not used the new type of HDPE before. Thoughts?