Articles with "considerations fda" as a keyword



Practical Considerations of FDA’s CLAP List to Support Testing of Extractables for Pharmaceuticals and Medical Devices

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Published in 2025 at "ACS Omega"

DOI: 10.1021/acsomega.5c01982

Abstract: The Chemical List for Analytical Performance (CLAP) was developed to support the chemical assessment of medical devices. FDA CDRH published the list, along with supporting data and with the intention that the chemicals in the… read more here.

Keywords: medical devices; practical considerations; clap list; considerations fda ... See more keywords