Patients are at the heart of what the FDA does and are vital to our work protecting the public health by ensuring the safety and efficacy of drugs, biological products, and medical devices. Your experience can help inform our understanding of your medical condition, as we move from early stages in research to the later stages of approving new products.


FDA Patient Engagement Overview

View a quick overview of  patient engagement  activities at FDA.

FDA Patient Engagement Partnerships

Learn  about the partnerships and collaborations that allow the FDA to learn and share ideas about patient engagement.

FDA Patient Engagement Opportunities

Read more about specific patient engagement opportunities available with FDA.


History of Patient Engagement at FDA

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    • Patient Preference Information (PPI) framework and guidance released for CDRH medical device decision-making

    • Patient Engagement Advisory Committee (PEAC) meeting launched to discuss medical devices

    • Internal working group established to discuss ways to increase Patient Involvement in FDA processes

    • New consumer-friendly form launched for reporting medical product problems through the FDA MedWatch system

    • Office of AIDS Coordination renamed to Office of AIDS and Special Health Issues (OASHI) with the scope expanded to include patients with cancer and other serious and life-threatening diseases

    • First FDA Patient Representative® served on an advisory committee

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