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This document details significant changes to the CPH3 205-TL-E and CPH3205-M-TL-E products, including updates to passivation, pad design, and wire qualification.
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What is final productprocess change notification?
A final product/process change notification is a formal notice submitted to regulatory authorities to inform them of changes made to a product or its manufacturing processes that may impact safety, efficacy, quality, or compliance.
Who is required to file final productprocess change notification?
Manufacturers or sponsors of medical products, including drugs, biologics, and medical devices, are required to file a final product/process change notification when significant changes occur.
How to fill out final productprocess change notification?
Filling out a final product/process change notification typically involves providing detailed descriptions of the changes, including rationale and any supporting data, and must be submitted through the designated regulatory portal or form specified by the authority.
What is the purpose of final productprocess change notification?
The purpose of the notification is to ensure transparency and compliance with regulations, allowing authorities to assess whether the changes affect the product's safety and effectiveness.
What information must be reported on final productprocess change notification?
The notification must include information about the product, the specific changes made, the rationale for those changes, potential impacts on safety and efficacy, and any supporting documentation.
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