The catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available.
“These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical technologies”, advises the Agency.
References are provided for each tool, but FDA explains that the tools do not replace FDA-recognized standards or qualified medical device development tools (MDDTs), continuing that it has not evaluated the suitability of the tools within any specific context of use.
FDA further explains that “An essential role of the Office of Science and Engineering Labs is to use the most innovative science to speed medical device development and patient access to safe and effective medical devices by producing tools to help in the assessment of new medical devices.”
Further information about the catalog can be obtained from here.