Modifications to the PMA Supplement Types After PMA Approval
The FDA uses a PMA (premarket authorization) to approve medical device manufacturers in order to bring them onto the American market. Once the PMA has passed, the manufacturer can apply the PMA supplement to make modifications to the device. PMA supplements may include modifications to the device’s design, components or labeling. Requests for material, information or drawings regarding the device are also possible (Khader 2018, 2018). PMA supplements may also be used to make changes at manufacturing sites (name, address, scope and activity) or modify an FDA-approved subassembly. (FDA 2020). You can use subsequent supplements to meet post-market clinical monitoring requirements. This includes changes in the labeling or conditions of approval. All these modifications help ensure the safety and effectiveness the medical device, as well the public’s health. Cont…
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