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  1. Science and Research (Medical Devices)

Catalog of Regulatory Science Tools to Help Assess New Medical Devices

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Scientist using microscope - Catalog of Regulatory Science Tools

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 and plans to expand as new tools become available.

These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical technologies. We have provided references for each tool. These tools do not replace FDA-recognized standards or qualified medical device development tools (MDDTs). The FDA has not evaluated the suitability of these tools within any specific context of use.

An essential role of the Office of Science and Engineering Labs is to use the most innovative science to speed medical device development and patient access to safe and effective medical devices by producing tools to help in the assessment of new medical devices.

For more information about the Catalog of Regulatory Science Tools, email OSEL_CDRH@fda.hhs.gov


Types of tools:


Phantoms

Phantom Name Description Type Areas Reference
Nanostructured Virus-simulating Phantoms for Evaluating Optical Biosensing Methods A shelf-stable, biohazard-free viral particle phantom for evaluation of optical biosensing methods Physical Medical imaging and diagnostics Article
Photoacoustic Imaging Phantoms for Assessing Image Quality and Oximetry Performance A set of breast-mimicking phantoms and associated performance test methods for evaluating photoacoustic imaging devices Physical Medical imaging and diagnostics Article
Retina Phantom for Optical Coherence Tomography (OCT) Medical Devices A retina phantom for evaluation of OCT imaging systems Physical Medical imaging and diagnostics Article
Tissue-Mimicking Material for Acoustic Preclinical Performance Characterization of High Intensity Therapeutic Ultrasound Devices Nonclinical assessment model for formulation and characteristics of a hydrogel-based tissue mimicking material (TMM) Physical Therapeutic ultrasound Article
Blood Mimicking Fluid for High Intensity Focused Ultrasound A blood mimicking fluid (BMF) for the acoustic and thermal characterizations of high intensity focused ultrasound (HIFU) ablation devices Physical Therapeutic ultrasound Article
VICTRE:  Multi-modality Anthropomorphic Breast Phantom A digital breast phantom with modifiable parameters including phantom voxel size (resolution) and breast density Virtual Medical imaging and diagnostics GitHub
Document

Methods

Method Name Description Type Areas Reference
ECG Artifacts for Algorithm Testing A method to estimate device-specific noise from ECG records for algorithm testing Lab Method

Cardiovascular
Patient monitoring and control

Article
Rapid Detection of Bacterial Endotoxins in Ophthalmic Viscosurgical Device Materials A Mass Spec method for evaluation of endotoxin contamination in medical device materials Lab Method Biocompatibility/toxicology Ophthalmology Article
Automated Rapid Accelerated Aging (Automated RAA) An in vitro test platform for expedite durability testing of neural implants Lab Method Biocompatibility/toxicology
Neurology
Article
Modified Dot-Blot Method to Evaluate PPEs An improved and faster method for viral challenge testing of PPE materials Lab Method Biocompatibility/toxicology Article
Genotoxicity Assessment of Nanomaterials A revised genotoxicity test battery for NanoMaterials (NMs) and recommendations to avoid interference Lab Method Biocompatibility/toxicology
Nanotechnology
Article
Reactive Accelerated Aging (RAA)  A simple and robust platform for comprehensive study of the reliability of neural implants  Lab Method Biocompatibility/toxicology
Neurology
Article
Screening of Contaminants in Glycerol-based Medical Products A rapid and simplified method for the detection and quantification of Jatropha-derived phorbol esters (PE) toxins  Lab Method Biocompatibility/toxicology Article
Frictional Test Method to Detect Likelihood of Coating Abrasion in Guidewires A test method for demonstration of coating integrity and durability during abrasion testing and evaluating bench coating performance Lab Method Materials performance Article
Flow Phantom Fabrication Using Inkjet (Polyjet) Additive Manufacturing A lab method for fabrication of flow phantoms using common additive manufacturing approach Lab Method Additive manufacturing Article
Targeted Box and Blocks Test (tBBT) A performance-based method requiring controlled grasping, transport, and release of objects that can be used to evaluate upper limb functional ability. Clinical Outcome Assessment  Orthopedics
Neurology
Article
One-hour Screening of Adulterated Heparin One-hour Screening of Adulterated Heparin by Simplified Peroxide Digestion and Fast RPIP-LC-MS(2) Lab Method Biocompatibility/toxicology Article
Imaging underneath a transparent stimulation electrode A method for real-time optical study of electrical stimulation dosimetry on tissue for safety
 
Lab Method Neurology
Orthopedics
Ophthalmology
Article
Quantitative evaluation of endoscope geometric distortion A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion Lab Method Medical imaging and diagnostics Article
Measurement of endoscope field of view A method that can measure the traditional cone-shaped field of view of all endoscopes Lab Method Medical imaging and diagnostics Article
Assessing texture reproduction of camera-phone-based medical devices A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target Lab Method Medical imaging and diagnostics Article
Laboratory accuracy evaluation of infrared thermographs Best practices for standardized performance testing of infrared thermographs intended for fever screening Lab Method Medical imaging and diagnostics Article
Wireless coexistence evaluation in the 5 GHz band with LTE-LAA signals Method to evaluate wireless-enabled medical devices in the 5 GHz band for coexistence with LTE-LAA systems Lab Method Electromagnetic & electrical safety Article
Estimating the likelihood of medical device wireless coexistence using logistic regression 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 Lab Method Electromagnetic & electrical safety Article
Method for addressing Bluetooth wireless coexistence Method for addressing wireless coexistence for Bluetooth enabled medical devices Lab Method Electromagnetic & electrical safety Article
Method for addressing Wi-Fi wireless coexistence Method for addressing wireless coexistence for Wi-Fi enabled medical devices Lab Method Electromagnetic & electrical safety Article
Method for analysis of computational model identifiability Method and software code to provide a quantitative measure and graphical analysis of model identifiability (i.e., over parametrization) applicable to multiscale models Lab Method Cardiovascular
Credibility assessment in modeling
Article
Info
Code
Benchmark problems for verifying cardiac electrophysiological models A series of benchmark problems with known exact solutions that can be used to verify if tissue-level (e.g., ventricular, atrial) computational models of cardiac electrophysiology have been implemented correctly Lab Method Cardiovascular
Credibility Assessment in Modeling
Article
easyPEASI: Easy perturbation EEG algorithm for spectral importance A simple method to identify frequency bands of importance in EEG-driven machine learning models 
 
Lab Method Neurology
Artificial intelligence/machine learning
Article
GitHub
Consistency metrics for quantitative electroencephalography Data-driven non-parametric methods to evaluate intra-subject and inter-subject consistency of quantitative EEG biomarkers  Lab Method Neurology Article
GitHub
Confocal Laser Methods (CLM) for quantitative evaluation of dioptric power characteristics of intraocular lens (IOL) implants A series of CLM test methodologies for precise quantitative evaluation of dioptric power characteristics of current and new technology IOL implants Lab Method Ophthalmology Patent
Patent
Dual-confocal laser caliper test method for refractive index and thickness measurements A dual-confocal laser caliper test method for noncontact high-precision sensing and measuring thickness and refractive index of intraocular lens (IOL) implants, thin films and tissue  Lab Method Ophthalmology
Laser therapeutics
Patent
Scanning light scattering profiler (SLSP) method for quantitative evaluation of light scattering A full-angle scanning light scattering profiler (SLSP) test methodology for quantitative evaluation of forward and backward light scattering from intraocular lenses (IOL) implants and other scattering materials and tissue  Lab Method Ophthalmology  
Laser therapeutics
Article
Article
Use of Newtonian Analog Fluids and 3D Printing to Evaluate Flow Rates of Diets in G-Tubes 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 Lab Method Post Market
Signal Response;
Material Performance
Article
Article
Novel In vitro Buckling Test Approach for the Next Generation of Transvenous Cardiac Leads A test method mimicking in vivo physiological service conditions for measuring buckling loads at the distal tip of transvenous pacemaker or defibrillation leads during motion characterized by the cardiac lead's bending or buckling in vivo Lab Method Cardiovascular Article
Considerations for Accelerated Wear Durability Testing for Transcatheter Heart Valves Heart valve leaflet damage patterns can be different based on the deformation of the valve leaflets. Free-edge tearing and commissure tears were the leading cause of valve hydrodynamic incompetence. Mechanical wear after accelerated wear durability testing of heart valve pericardial leaflets affects differently based on whether they are undistorted, stretched, or sagging in a valve configuration Lab Method Cardiovascular Article

Computational Models and Simulations

Model or Simulation Name Description Type Areas Reference
VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation An entirely in-silico imaging clinical trial replicating a premarket study. Model Medical imaging and diagnostics GitHub
Article
VICTRE: Breast Cropping Software A computational tool that crops parts of the breast phantom that are not directly in the path of the x-ray source between compression surfaces Model Medical imaging and diagnostics GitHub
VICTRE: Breast Mass Generation Software A modeling software that randomly generates main body of breast masses including random branching spicules grown out from the mass surface Model Medical imaging and diagnostics GitHub
VICTRE: Model Observers (MO) Computer model observer functions to perform location-known lesion detection tasks Model Medical imaging and diagnostics GitHub
VICTRE: Anthropomorphic Breast Phantom Compression Software A modeling software of physical compression that breasts undergo during mammographic imaging Model Medical imaging and diagnostics GitHub
VICTRE_MCGPU: Pivotal Study Simulations A simulation tool that replicates a Siemens Mammomat Inspiration system for VICTRE Model Medical imaging and diagnostics GitHub
iMRMC: Multi-Reader Multi-Case Reader Studies Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies Model Imaging reader studies, Artificial intelligence/machine learning GitHub
iRoeMetz Application A java application used to simulate reader scores for multi-reader multi-case (MRMC) reader studies Model Imaging reader studies, Artificial intelligence/machine learning GitHub
eeDAP: Evaluation Environment for Digital and Analog Pathology A software and hardware platform for designing and executing digital and analog pathology studies. Model Digital pathology GitHub
Color Scale Study Data Color scale study repository for Cardiac CT and Prostrate MRI Studies Model Artificial intelligence/machine learning GitHub
MIDA: A Multimodal Imaging-Based Detailed Anatomical Model of the Human Head and Neck A tool to generate computational scientific evidence as alternative approaches to clinical Model Neurology
Orthopedics
Medical imaging and diagnostics Ophthalmology Electromagnetic and electrical safety
Article
CHRIS: Color Hazard and Risk Calculator Rapid (screening level) risk assessments of color additives in medical devices Model Biocompatibility/toxicology Orthopedics Article
High Intensity Therapeutic Ultrasound (HITU) Simulator v2.0 MATLAB-based, user-friendly, and freely available software package for simulating axisymmetric nonlinear pressure fields, computing thermal effects, and validating against experiment Model Therapeutic ultrasound GitHub
Info
CFD/6DOF Model of Clot Transport and Capture in an IVC Filter A computer simulation for prediction of the capture efficiency of IVC filters Model Cardiovascular Article
Article
Kriging Surrogate Modeling for Hemolysis  Computer simulation for estimation and optimization of empirical constants in hemolysis models Model Cardiovascular Article
VICTRE: Digital Mammography Regions of Interest (ROIs) VICTRE ROI patches for digital mammography of breast density categories with microcalcification cluster and spiculated mass inserted signals. Dataset Medical imaging and diagnostics GitHub
Multivariate Physiological Signals During Hemorrhage A set of hemodynamic, cardiovascular and pulmonary variables measurements  Dataset Cardiovascular Article
Benchmark PIV Dataset for Laminar Flow in an Anatomically Realistic IVC Velocity and hemolysis datasets to improve the predictive capability of CFD simulations in the evaluation of medical devices. Dataset Cardiovascular

Article
Article

Interlaboratory Characterization of the Velocity Flow Field in the FDA Blood Pump Model Using Particle Image Velocimetry Experimental datasets for verification, validation, uncertainty quantification, and credibility assessment of CFD simulations in the evaluation of medical devices Dataset Cardiovascular Article
Benchmark Datasets for Validation of Computational Fluid Dynamics Models Experimental datasets of velocity and pressure on simplified medical devices used to validate computational fluid dynamic (CFD) models Dataset Cardiovascular Wiki
The Virtual Family: A set of anatomically correct whole-body computational models The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children Model Neurology
Orthopedics
Medical imaging and diagnostics
Ophthalmology
Electromagnetic & electrical safety
Info
Computational model of the human cardiac action potential Model and software of the human action potential appropriate for simulating arrhythmia initiation in human hearts Model Cardiovascular Article
Code
Computational model of the rabbit cardiac action potential Parsimonious (reduced complexity) model and software of the rabbit action potential amenable to large scale simulations of arrhythmias Model Cardiovascular Article
Code
MC-GPU: GPU-accelerated Monte Carlo simulation of x-ray transport 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. Model Medical imaging and diagnostics GitHub
Mammoreplicator Software tool to create 3D printed phantoms that replicate the attenuation profile observed in real 2D mammograms. The software processes an input mammogram to estimate the amount of x-ray attenuation at each pixel, and outputs a printable triangle mesh object that encodes the observed attenuation map. Model Medical imaging and diagnostics GitHub
MSim3V_IA: design of test objects and tissue substitutes for radiologic applications Software tool to design material combinations that match the x-ray attenuation profile of real tissue, and that can be used as a substitute of biologic tissue in anatomical phantoms for x-ray imaging device evaluation. Model Medical imaging and diagnostics GitHub
Computational Simulation of Clinically Relevant Bioprosthetic Valve Performance Metrics The effects of deformed valve annulus configurations on a surgical bioprosthetic valve were investigated as a model for transcatheter heart valves. Valve leaflet motions, stresses and strains, and analogue hydrodynamic measures (using geometric methods), via finite element modeling. This study adds more evidence for considering the clinical impacts of transcatheter heart valve deformation on acute and long-term valve performance in the design and testing phase of device development Model Cardiovascular Article
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