When a manufacturer desires to make a change to a Class III device that has been approved via a Premarket Approval (PMA) or product development protocol (PDP) that affects the device’s safety and effectiveness (new indication for use, a change to the labeling, new manufacturing site, etc.) or a change to a Humanitarian Device Exemption (HDE) that affects its safety and probable benefit, a supplement application is required.
This article explores the different types of published literature that can support Class III Medical Device submissions for FDA compliance.
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