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.
Tools that quantify wait-time-saving benefits for cases with positive diagnoses due to the adoption of Computer-Aided Triage and Notification devices in a radiology workflow
A statistical approach for estimating the likelihood of wireless coexistence of a medical device in its intended environment based on experimental evaluation and realistic environment measurements
Method to fabricate realistic microcalcification simulants with adjustable density and sizes, for insertion into phantoms used to evaluate x-ray breast imaging systems
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.
A tool to generate computational scientific evidence as alternative approaches to clinical
An improved and faster method for viral challenge testing of PPE materials
A computational modeling tool that provides first-pass estimation of the thermal effect produced in the vaginal wall by vaginal therapy devices.
Parsimonious (reduced complexity) model and software of the rabbit action potential amenable to large scale simulations of arrhythmias
Tool for assessing image quality of advanced nonlinear CT image reconstruction and denoising products, including but not limited to statistical iterative, model-based iterative, and deep learning-based methods
Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation Under Fatigue Loading
Recommended best practices for executing in vitro human cadaver fatigue loading and multidirectional flexibility assessment of lumbar integrated fixation device constructs.
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 tool provides protocols for conducting preclinical tests recommended in the FDA Guidance for tissue containment systems used during power morcellation procedures.
A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target
A Method Using 3D Printed Surrogate G-Tubes and Newtonian Analog Fluids to Compare the Flow Rates with Commercial Diets in G-Tubes with the New ISO 80369-3 Connector
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’
Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies
Best practices for standardized performance testing of infrared thermographs intended for fever screening
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
A method to estimate device-specific noise from ECG records for algorithm testing