The Care And Feeding Of FDA PMAs: Mastering Premarket Approval

The article discusses the critical role of the FDA's Premarket Approval (PMA) process for medical devices, highlighting the importance of post-approval management to ensure continued compliance and market access. Securing a PMA signifies a device's safety and effectiveness, but maintaining this status requires adherence to specific conditions, such as post-approval studies, annual reporting, and device tracking. Annual reports are essential for updating the FDA on device performance and any design changes, which must be justified to ensure they do not compromise safety or effectiveness. Learn more about the FDA's control over labeling changes, particularly those involving warnings or contraindications, which may require review and approval.
Additionally, the document underscores the need for a comprehensive summary and bibliography of scientific investigations and literature not included in the original PMA submission, as well as a detailed complaint listing and information on devices shipped or sold. The FDA's review process for PMA Annual Reports involves acknowledging receipt, requesting additional information, or determining if changes require a supplement. Expand your knowledge of effective PMA management, including diligent oversight, record-keeping, and proactive communication.
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