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Terms Beginning with P
       
       
 

PMA Pre-Marketing Approval

Health Care Term


PMA, or Pre-Marketing Approval, is a regulatory process that is utilized by the United States Food and Drug Administration (FDA) to evaluate and approve Class III medical devices before they can be marketed and used in the healthcare industry. This process is lengthy and complex, and involves the submission of extensive documentation and data on the device's safety, effectiveness, and manufacturing processes.

The PMA process is reserved for medical devices that are considered high-risk, such as implantable devices or devices that sustain or support life. Before a manufacturer can submit a PMA application, they must have completed extensive testing and clinical trials to demonstrate the safety and efficacy of their device.

Once a PMA application has been submitted, the FDA conducts a thorough review of the application and supporting documentation. This review process can take several years, and may involve additional testing or trials if the FDA identifies any concerns or issues with the device's safety or effectiveness.

If a PMA application is approved, the FDA will grant the manufacturer permission to market and distribute the device in the United States. The device will also be subject to ongoing post-marketing surveillance and monitoring to ensure that it continues to meet safety and effectiveness standards.

Overall, the PMA process plays a crucial role in ensuring that only safe and effective medical devices are marketed and used in the healthcare industry. This helps to protect patient health and safety, and supports the development of new and innovative medical technologies.


   
     

PMA Pre-Marketing Approval

Health Care Term


PMA, or Pre-Marketing Approval, is a regulatory process that is utilized by the United States Food and Drug Administration (FDA) to evaluate and approve Class III medical devices before they can be marketed and used in the healthcare industry. This process is lengthy and complex, and involves the submission of extensive documentation and data on the device's safety, effectiveness, and manufacturing processes.

The PMA process is reserved for medical devices that are considered high-risk, such as implantable devices or devices that sustain or support life. Before a manufacturer can submit a PMA application, they must have completed extensive testing and clinical trials to demonstrate the safety and efficacy of their device.

Once a PMA application has been submitted, the FDA conducts a thorough review of the application and supporting documentation. This review process can take several years, and may involve additional testing or trials if the FDA identifies any concerns or issues with the device's safety or effectiveness.

If a PMA application is approved, the FDA will grant the manufacturer permission to market and distribute the device in the United States. The device will also be subject to ongoing post-marketing surveillance and monitoring to ensure that it continues to meet safety and effectiveness standards.

Overall, the PMA process plays a crucial role in ensuring that only safe and effective medical devices are marketed and used in the healthcare industry. This helps to protect patient health and safety, and supports the development of new and innovative medical technologies.


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