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.
A computational modeling tool that provides first-pass estimation of the thermal effect produced in the vaginal wall by vaginal therapy devices.
A tool to generate computational scientific evidence as alternative approaches to clinical
This study demonstrates the application of gold-standard method of manufactured solutions (MMS) code verification to verify a commercial finite element code for elastostatic solid mechanics analyses relevant to medical devices. The Python/SymPy code used to generate source terms is available as supplemental material.
MC-GPU is a Monte Carlo simulation code that can generate synthetic radiographic images and computed tomography (CT) scans of realistic models of the human anatomy using fast Graphics Processing Unit (GPU) cards.
This regulatory science tool presents a computer model to assist investigators with analyzing and sizing multi-reader multi-case (MRMC) reader studies that compare the difference in the area under Receiver Operating Characteristic curves (AUCs) from two modalities.
A finite element model of the human shoulder for simulating humeral abduction and calculating outputs such as contact force, contact pressure, contact area, stress, and strain.
An approach for optimal experimental design and estimability analysis for mechanistic models of cardiac electrophysiology to determine their ‘identifiability’
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.
A software program written in Matlab for analyzing color performance testing data in endoscopy devices
Predicts the impact of extraction conditions, sample geometry and material properties on extraction test efficiency
CHemical RISk calculators (CHRIS) – Color Additives (v2)
Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components
An implementation of a canine action potential model appropriate for comprehensive parameter sensitivity analysis and uncertainty quantification
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.