Regulatory Science Tools to Accelerate Medical Device Innovation: FDA Voices
As the rate of technological advances moves faster than the science for evaluating the benefits and risks of new products, the FDA’s Center for Devices and Radiological Health (CDRH) is helping to ensure that device developers have the right test methods to evaluate new innovations.
The Catalog of Regulatory Science Tools collates a variety of regulatory science tools that CDRH’s Office of Science and Engineering Labs (OSEL) has developed, with new tools added as they become available. These methods expand the scope of innovative science-based approaches to improve the development and assessment of emerging medical technologies. The catalog includes more than 100 tools, including laboratory methods, tissue-mimicking phantoms, and computational modelling and simulations
In addition to helping device developers identify appropriate tools for their needs, the catalog entries include detailed instructions for use and, where appropriate, reference to the original peer reviewed source for further detail.
The catalog includes more than 100 tools, including laboratory methods, tissue-mimicking phantoms, and computational modelling and simulations. In March 2021, the FDA added 19 tools to the catalog:
- Correction for Hydrophone Spatial Averaging Artifacts for Circular Sources
- Experimental and computational methods for the acoustic and thermal characterization of therapeutic ultrasound fields
- Acoustic power calibration of high-intensity focused ultrasound transducers using a radiation force technique
- Framework for quantitatively estimating ultrasound beam intensities using infrared thermography
- Full-Field Microscale Strain Measurements of a Nitinol Medical Device Using Digital Image Correlation
- An in vitro blood flow loop system for evaluating the thrombogenicity of medical devices and biomaterials
- A Reusable, Compliant, Small Volume Blood Reservoir For In Vitro Hemolysis Testing
- Limitations of using synthetic blood clots for measuring in vitro clot capture efficiency of inferior vena cava filters
- Plasma hemoglobin measurement techniques for the in vitro evaluation of blood damage caused by medical devices
- Quantification by mass of residual debris in reusable medical devices
- Method of Manufactured Solutions Code Verification of Elastostatic Solid Mechanics Problems in a Commercial Finite Element Solver
- Use of the FDA Nozzle Model to Illustrate Validation Techniques in Computational Fluid Dynamics (CFD) Simulations
- Verification benchmarks to assess the implementation of computational fluid dynamics based hemolysis prediction models
- Fluid-Structure Interaction (FSI) Models of Bioprosthetic Heart Valve Dynamics (BHV) in an Experimental Pulse Duplicator
- Orthopaedic SMART Devices Roadmap
- Spinal Growing Rod Mechanical Performance Testing
- Integrated Fixation Cage Fatigue Testing
- Considerations for the selection of specimen size for cyclic potentiodynamic polarization corrosion susceptibility testing
- Considerations for the pre-conditioning of specimens for cyclic potentiodynamic polarization corrosion susceptibility testing
Questions?
If you have questions about this catalog of regulatory science tools, email OSEL_CDRH@fda.hhs.gov.
|
