In mid-October 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program to provide consumers and health care professionals with crucial information about clinical trials that supported the FDA’s approval of new medical devices. This program is modeled after the Center for Drug Evaluation and Research (CDER) drug trials snapshots program. The medical device pilot program is part of the FDA’s ongoing effort to increase transparency around diversity of clinical trial participants in studies of novel medical products. Each device trial participation snapshot provides:
- general information about what the device is, how it works, when it can be used, and benefits and risks of use,
- who was represented in clinical studies of new medical technology (demographics including sex, age, race, ethnicity), and
- whether there were any reported differences in the benefits and risks in different groups.
Snapshots are currently available for approvals of only higher risk devices approved under original premarket approval (PMA) applications from April to July 2024. The snapshots provide information available at the time of approval, and the FDA does not plan to update them over time with real-world post marketing data.
Comments on the snapshots pilot program may be submitted to www.Regulations.gov under docket number FDA-2024-N-4561 by January 13, 2025.