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 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 (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.
The Evaporation tool provides a predictive model for estimation of the recovery of analytes in chemical characterization studies following concentration through rotary evaporation or nitrogen blowdown.
This regulatory science tool is a model for establishing analyte recovery in chemical characterization studies following liquid-liquid extraction.
Chemicals List for Analytical Performance (CLAP)
This tool provides protocols for conducting preclinical tests recommended in the FDA Guidance for tissue containment systems used during power morcellation procedures.
A Method Using 3D Printed Surrogate G-Tubes and Newtonian Analog Fluids to Compare the Flow Rates with Commercial Diets in G-Tubes with the New ISO 80369-3 Connector
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method