CDRH Industry: Public Workshop - Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices, May 2, 2016

The Food and Drug Administration (FDA) is announcing a public workshop titled, “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices” scheduled for May 2, 2016. The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The primary focus will be on the validation considerations with protein- and peptide-based LC/MS devices.