AB CDRH Meaning and
Definition
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AB CDRH stands for Accredited Persons Program (AB) conducted by the Center for Devices and Radiological Health (CDRH). The CDRH is a division within the U.S. Food and Drug Administration (FDA) responsible for ensuring the safety and effectiveness of medical devices and radiation-emitting products. The AB CDRH program is designed to streamline the process of reviewing and certifying medical devices, enhancing efficiency while maintaining rigorous standards.
Under the AB CDRH program, certain tasks related to premarket notification, also known as 510(k) clearance, can be delegated to private entities called Accredited Persons (APs). These APs are external organizations, such as testing laboratories or medical device manufacturers, that meet specific criteria and are accredited by the FDA. They have the necessary expertise and resources to evaluate medical devices and provide expert recommendations to the FDA regarding their safety and effectiveness.
The AB CDRH program allows APs to review low-to-moderate-risk medical devices, reducing the burden on the FDA's resources while ensuring timely access to safe and effective medical devices for patients. APs conduct their assessments according to applicable regulations and guidance documents established by the FDA, providing comprehensive evaluations and recommendations to the FDA for market clearance. This program aims to expedite the review process while upholding the high standards of safety and effectiveness required for medical devices sold in the United States.
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