27/28 April 2021
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:
The Catalog of Regulatory Science Tools to Help Assess New Medical Devices is available on the FDA website.