The Food and Drug Administration (FDA) has announced a new pilot program through its Center for Devices and Radiological Health (CDRH) to provide greater transparency regarding clinical trials for medical devices. This initiative, modeled after the Center for Drug Evaluation and Research (CDER) drug trials snapshots program, aims to offer consumers and healthcare professionals crucial information about the participants and outcomes of clinical studies supporting the approval of new medical devices.
The device trial participation snapshots address key questions about who participated in the clinical studies and how the devices performed across different demographic groups. These snapshots are currently available for higher-risk devices approved under original premarket approval (PMA) applications between April and July 2024. The FDA emphasizes that the snapshots reflect information available at the time of approval and will not be updated with real-world data over time.
This pilot program is part of the FDA's ongoing efforts to enhance transparency and promote diversity in clinical trial participation for novel medical products. By providing detailed information about the demographics of trial participants, the FDA hopes to foster greater understanding and trust in the regulatory process.
Feedback Opportunity
The FDA is soliciting feedback on the snapshots pilot program. Interested parties can submit comments via www.Regulations.gov under docket number FDA-2024-N-4561 until January 13, 2025. This feedback will help the agency refine and improve the program to better serve the needs of patients and healthcare providers.
