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.
Non-clinical biomarkers of brain injury derived from epidermal and epidural electroencephalographs
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
A tool to assist with evaluating and quantifying contractile response of non-excitatory electrical stimulation signals including CCM in vitro using 2D human cardiomyocyte models
A simple and compliant fluid reservoir appropriate for in-vitro blood trauma testing.
Provides 16 mock intervertebral body fusion device (that is, a spinal cage) designs with three lattice structure implementations. Designs are provided in stereolithography (STL) file format so they may be fabricated using additively manufacturing (AM) technologies.
This tool provides a step-by-step protocol to design a recirculating flow loop test system and perform in vitro thrombogenicity testing of catheter-like blood-contacting medical devices and materials using blood from several animal species. The protocol also provides details about different markers for thrombogenicity testing.
A "threshold-based" validation approach that provides a well-defined acceptance criterion, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity.
An implementation of a canine action potential model appropriate for comprehensive parameter sensitivity analysis and uncertainty quantification
Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components
CHemical RISk calculators (CHRIS) – Color Additives (v2)
Predicts the impact of extraction conditions, sample geometry and material properties on extraction test efficiency
A software program written in Matlab for analyzing color performance testing data in endoscopy devices