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 quantitative optical coherence tomography angiography (qOCTA) method to measure the absolute velocity of individual blood cells within retinal microvasculature and map 3D flow rates.
This regulatory science tool (RST) is a lab method for absolute vessel caliber and retinal blood flow velocity measurements in humans using a high-resolution (spatial and temporal) multimodal adaptive optics system with scanning laser ophthalmoscopy (SLO) and optical coherence tomography (OCT).
This regulatory science tool (RST) is an adaptive optics – optical coherence tomography angiography (AO-OCTA) method to resolve and quantify retinal vessels including the choriocapillaris (CC) in the living human eye, along with a dataset of CC montages and their morphologic metrics across the macula from healthy individuals. This RST has multiple purposes: 1. It offers one possible approach for performing OCTA for vessel imaging; 2. It describes an approach for measuring CC image quality using a new flow signal to noise ratio (SNR) metric; 3. The dataset can serve as a normative baseline for future studies of retinal pathology and as labelled ground truth data for the assessment of novel algorithms for CC segmentation.
This regulatory science tool (RST) is a lab method for evaluating the safety of critical time-dependent radiant power, spectral, and temporal characteristics for multiwavelength high-power laser pointers and handheld compact laser products