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US FDA issues guidance on changes to devices subject to PMAs

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has issued final guidance on the types of regulatory submissions that sponsors need to make if their legally marketed medical device (subject to premarket approval) undergoes any modifications, such as changes to device design, labelling and the manufacturing process1,2. The guidance also applies to Class III devices that undergo a recall or a field corrective action where the manufacturer needs to change the device to assure safety and effectiveness.

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