U.S. Food and Drug Administration

This regulatory science tool (RST) is a lab method that is intended to assist in the detection and quantification of volatiles in aqueous extracts using dynamic headspace gas chromatography-mass spectrometry.

Registration-based Automated Matching and Correspondence (RAMAC) is a tool that automatically identifies corresponding locations of landmarks across multiple images.

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 laboratory method that calculates the Contrast Transfer Function (CTF) of Augmented Reality (AR) and Virtual Reality (VR) head mounted displays (HMDs) by quantifying the Michelson contrast as a function of spatial frequency for horizontal or vertical grille patterns displayed on the HMD.

This regulatory science tool (RST) is a laboratory method for measuring the spatial resolution of optical see through augmented reality head mounted displays (AR HMDs) using point spread function analysis.

This Regulatory Science Tool (RST) is a Laboratory Method outlining the use of a hydrogen peroxide solution to screen for oxidative degradation. This method allows for maintenance, monitoring and reporting of solution concentration and oxidative capacity and (iii) is demonstrated with UHMWPE as a non-resorbable polymer susceptible to oxidative degradation.

This regulatory science tool is a laboratory method for measuring fit-factor of re-used and/or decontaminated N95 respirators using adult manikins.

This regulatory science tool (RST) is a dataset of whole slide images and pathologist annotations for use in the development of new statistical methods.

This regulatory science tool (RST) is a phantom that enables image quality assessment of ophthalmic optical coherence tomography (OCT) devices.

This regulatory science tool (RST) is a benchtop test method for performing material-mediated thrombogenicity assessment of blood-contacting medical devices and materials using molecular biomarkers to characterize platelet and coagulation activation in a single set of tests.