PAS CDRH Meaning and
Definition
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PAS CDRH refers to the Post Approval Study Compliance and Enforcement Program of the Center for Devices and Radiological Health (CDRH) within the U.S. Food and Drug Administration (FDA). The CDRH is responsible for ensuring the safety and effectiveness of medical devices and radiation-emitting products in the United States.
PAS CDRH is a regulatory program designed to monitor and enforce compliance with the post-approval study requirements established by the FDA for certain medical devices. After a medical device receives FDA approval or clearance, the manufacturer may be required to conduct post-approval studies to gather additional data on the device's safety and effectiveness in real-world use.
The PAS CDRH program aims to ensure that manufacturers are in compliance with these post-approval study requirements. It involves the FDA's ongoing monitoring and assessment of the manufacturers' progress and adherence to the study protocols. The program also includes enforcement actions to address non-compliance, such as issuing warning letters, product recalls, or imposing penalties.
The purpose of PAS CDRH is to protect public health by ensuring that medical devices in the market continue to demonstrate safety and effectiveness after they have been approved or cleared by the FDA. By monitoring post-approval studies, the CDRH can identify any potential issues or risks associated with the devices and take appropriate actions to mitigate them.
In summary, PAS CDRH is a regulatory program within the FDA's CDRH that monitors and enforces compliance with post-approval study requirements for medical devices to ensure their continued safety and effectiveness.
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