FDA Publishes Catalog of Tools for the Development of New Medical Devices
Recommendation

5/6 February 2026
A Tool to get Process Understanding
Medical devices are essential medical tools and that is why health authorities are also interested in their development. For this purpose, the FDA has presented a catalog of tools.
The catalog lists a number of different regulatory, scientific tools developed by FDA's Center for Devices and Radiological Health (CDRH) and the Office of Science and Engineering Labs (OSEL). This list is planned to be expanded as new tools become available.
The goal is to use these tools in an innovative science-based approach to improve the development of important medical technologies. The FDA has assigned a reference to each of these tools. However, they are not intended to replace the existing FDA recognized "medical device development tools (MDDTs)".
The list is divided into three categories:
- "Phantoms"
- Methods
- Computational Models and Simulations
The Catalog of Regulatory Science Tools to Help Assess New Medical Devices is available on the FDA website.
Related GMP News
06.11.2025FDA Warning Letter Statistics on Medical Devices in the Past Fiscal Year 2025
06.11.2025FDA Breakthrough Device Program
06.11.2025US President Trump extends Transition Period for EtO Sterilisation
16.10.2025Overview of the FDA's new Quality Management System Regulation: effective from 2 February 2026
16.10.2025Survey of Notified Bodies on the Certification Procedure for Medical Devices
10.09.2025Artificial Intelligence in Medical Devices - the Perspective of Notified Bodies


