Aug 26, 2020

The US FDA published a catalog of regulatory science tools intended to help in assessing new medical devices. These tools were developed by the Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) to expand the scope of science-based approaches used in the development of emerging medical technologies. The introduction to the catalog states that the FDA has not evaluated whether these tools are suitable for specific uses, further noting that the tools do not replace FDA-recognized standards or qualified medical device development tools (MDDTs).

Tools are intended to add speed and consistency to medical device development

The tools are accompanied by references linking to scientific journal articles and/or user-end documentation, sometimes in the form of GitHub libraries. The catalog is organized into three categories: phantoms (i.e., materials that mimic the behavior of human tissues under laboratory conditions), methods, and computational models and simulations. Users can also search for specific terms in the catalog, sort results by field, or export lists to Excel spreadsheets.

It is OSEL’s mission to produce tools that accelerate the pace of medical device development by providing innovative methods with which to assess devices under development. Prior to the creation of the office’s MDDT program, tools utilized by developers had to be evaluated by the FDA on a case-by-case basis, adding time to the process and undermining consistency. By providing tools that the Agency has determined to be acceptable for designated purposes, the FDA hopes to streamline the review process and concentrate attention on its most critical aspects.

Related US FDA medical device and IVD regulatory resources:


  • Timothy Herr