Update: Clinical Outcome Assessments Case Studies

Read about new case studies on the use of COAs in medical device evaluation.

If your email program has trouble displaying this email, view as a webpage. Update on Clinical Outcome Assessments Use in Medical Device Decision Making Today, the U.S. Food and Drug Administration (FDA) updated information on the FDA's website about the use of Clinical Outcome Assessments (COAs) in the evaluation of medical devices. COAs provide information about a patient's health status such as how the patient feels, functions, or survives. The FDA considers high-quality information from COAs as evidence in benefit-risk assessments in regulatory decision making. The update highlights case studies on the use of COAs to support medical device evaluation. Read More Questions? If you have questions about clinical outcome assessments, email CDRH-PRO@fda.hhs.gov.

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