What Does SAER Stand For?

SAER stands for Standard Adverse Event Report Review CDRH

SAER, or Standard Adverse Event Report Review CDRH, refers to a systematic process established by the Center for Devices and Radiological Health (CDRH) to evaluate and analyze adverse event reports concerning medical devices. This process ensures that reported incidents are assessed consistently and thoroughly, promoting patient safety and regulatory compliance. SAER is critical for identifying trends, facilitating risk management, and informing post-market surveillance activities within the medical device industry.