Yes, the U.S. Food and Drug Administration (FDA) also considers changes to the materials used in a medical device to be part of the design changes. Changes to the materials can impact the device's performance, safety, and effectiveness, and therefore may require an amendment to the device's clearance or approval or a new clearance or approval application.
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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com3470 Superior Court
Oakville ON L6L0C4
Canada
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Original Message:
Sent: 08-Mar-2023 12:53
From: Anonymous Member
Subject: Design changes vs material change
This message was posted by a user wishing to remain anonymous
Folks,
would you guys consider materials changes as part of design changes?.our vendor is discontinuing the base material and other tie layers that they used to use to manufacture our raw material . so, they will give us an alternative material that will have the same thickness as current material. we are class I exempt ..