Regulatory Science Tools Catalog
The Regulatory Science Tools Catalog provides a peer-reviewed resource for use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This 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. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program.
This regulatory science tool is a method and phantom design for the evaluation of iodine-specific quantitative measurements, specifically the accurate estimation of iodine concentration within contrast-enhanced spectral CT.
This regulatory science tool presents a set of tissue-mimicking phantoms suitable for benchtop performance assessment of photoacoustic imaging (PAI) devices.
Method to fabricate realistic microcalcification simulants with adjustable density and sizes, for insertion into phantoms used to evaluate x-ray breast imaging systems
Digital model available on NIH's 3D Print Exchange site that can be used to fabricate tissue simulating phantoms with biomimetic vascular structures derived from a clinical image