EPD CDRH stands for Electronic Product Definition, Compliance, and Disclosure Reporting Handbook. It is a comprehensive guide published by the Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA).
The purpose of the EPD CDRH is to establish guidelines and regulations regarding electronic product definitions, compliance, and disclosure reporting in the medical device industry. It provides detailed instructions on how medical device manufacturers should document and disclose information about their products, ensuring transparency and accuracy for regulatory review and public information.
Within the EPD CDRH, manufacturers can find guidance on various aspects of medical device documentation, including labeling requirements, clinical data collection and study design, risk assessment, software validation, and manufacturing standards. The handbook also outlines the procedures for filing premarket notification (510(k)), premarket approval (PMA), and investigational device exemption (IDE) applications.
By following the guidelines set forth in the EPD CDRH, medical device manufacturers can ensure that their products comply with FDA regulations and can be evaluated efficiently and effectively by regulatory authorities. This helps to ensure the safety and efficacy of medical devices, safeguarding public health.
