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.
This regulatory science tool (RST) is a method for assessing the image quality of a head mounted display using the display’s transverse chromatic aberration characteristics to align the light measuring device to the eye-point/ center of the eye-box.
This regulatory science tool (RST) describes a method to characterize digital image quality on optical see-through augmented reality head-mounted displays (AR HMDs) in ambient lighting conditions. The method can be implemented to measure AR display performance, such as Michelson contrast and contrast uniformity.
This regulatory science tool is a method for measuring the line spread function (LSF) and calculating the modulation transfer function (MTF) for head mounted displays (HMDs).
This regulatory science tool presents a method to measure the radially variant contrast on virtual reality head-mounted displays (VR HMDs) using circular concentric ring patterns, which can be implemented to characterize image quality, including Michelson contrast and effective resolution, on VR HMDs equipped with optical lenses.
This tool allows for the creation of immersive 3D scenes using a web browser. WebXR allows for an instant deployment of any 3D scene and scripts and does not need to cater to a specific 3D engine or headset hardware