title: US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.
abstract: Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic.
authors.affiliation: Divisions of Hematology and Immunology Devices and julia.lathrop@fda.hhs.gov.
authors.forename: Julia Tait
authors.initials: JT
authors.lastname: Lathrop
authors.affiliation: Divisions of Hematology and Immunology Devices and.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Jeffery
authors.affiliation: Microbiology Devices, and Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, and.
authors.forename: Yvonne R
authors.initials: YR
authors.lastname: Shea
authors.affiliation: Division of Analytical Chemistry, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Silver Spring, MD;
authors.forename: Peter F
authors.initials: PF
authors.lastname: Scholl
authors.affiliation: Divisions of Hematology and Immunology Devices and US Food and Drug Administration (retired).
authors.forename: Maria M
authors.initials: MM
authors.lastname: Chan
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000592:standards; D019411:Clinical Laboratory Techniques / Q000295:instrumentation / Q000592:standards*; D006801:Humans; D013058:Mass Spectrometry / Q000295:instrumentation / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*