U.S. Food and Drug Administration

This regulatory science tool is a laboratory method for measuring fit-factor of pediatric facemasks.

This regulatory science tool (RST) provides a step-by-step protocol to design a 9.5 mm inner diameter recirculating flow loop test system and perform bench-top thrombogenicity testing of catheter-like blood-contacting medical devices and materials. Additionally, this tool describes a dynamic pump occlusion setting method to improve blood flow rate consistency between different roller pumps.

This regulatory science tool (RST) is a series of quasi-static isotropic material models for additively manufactured (AM) Titanium – 6 Aluminum – 4 Vanadium (Ti-6Al-4V) for use in finite element or other engineering analysis techniques.

This regulatory science tool (RST) is a browser-based resource for identifying a target speckle size and suitable patterning approach when planning digital image correlation (DIC) measurement studies of implantable medical devices.

This regulatory science tool (RST) is a Test Method to easily and efficiently assess the integrity of an additively manufactured (AM) medical device or component that is intended to seal air.

This regulatory science tool (RST) provides an applied credibility assessment plan for a computational model-based, patient-specific surgical planning workflow that predicts optimal patch shape in branch pulmonary artery reconstruction.

This regulatory science tool (RST) is a confocal laser method to evaluate the dioptric power of commercially available and new-technology intraocular lens (NTIOL) implants.

This regulatory science tool (RST) is a dual-confocal laser caliper test method for refractive-index and thickness measurement of intraocular lens (IOL) implants and thin films

This regulatory science tool (RST) is a scanning light scattering profiler (SLSP) method for quantitative evaluation and nonclinical measurement of light scattering characteristics of both current and new-technology intraocular lens (NTIOL) implants.

The Respirator Filtration Efficiency Calculator is a conservative computational tool that assists stakeholders with the assessment of personal protective equipment (PPE) textile materials, namely respirator / mask materials, to estimate particle filtration efficiencies compared with those of a reference surgical N95® respirator.