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Westside Union ESD Regular Meeting Board Packet Tuesday, February 19, 2019, Open Session: 5:00 PM Closed Session: 5:05 PM Reconvene to Open Session at 6:00 PM Hillview Middle School 41914 50th St
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Open Session PMA (Post-Market Approval) refers to a regulatory document required by the FDA that allows for the collection of post-market data regarding the safety and effectiveness of medical devices or drugs after they have been approved.
Manufacturers of medical devices and pharmaceutical products approved by the FDA are required to file open session PMA to report ongoing safety and effectiveness data.
To fill out open session PMA, manufacturers must gather data regarding product performance, adverse events, and any changes in manufacturing that could affect safety or efficacy, and then follow the FDA guidelines to submit this information.
The purpose of open session PMA is to ensure continuous monitoring of products post-approval, to assess long-term safety and effectiveness, and to identify any potential risks to public health.
Information reported on open session PMA must include clinical data, adverse event reports, modifications to the product, and any relevant changes in manufacturing processes.
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