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FDA Announces Public Workshop on LC/MS-Based IVD Test Validation, Requests Comments

NEW YORK (GenomeWeb) – The US Food and Drug Administration has announced a public workshop later this spring to discuss regulation of liquid chromatography/mass spectrometry-based in vitro diagnostic tests.

The May 2 workshop, entitled "Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices," will focus on validation of tests using protein and peptide biomarkers. The FDA is seeking electronic or written comments to be published as part of the workshop, due by April 20.

"Innovations in liquid chromatography-mass spectrometry (LC/MS) technology have dramatically improved assay throughput and precision," the FDA said in the notice, published March 9 in the Federal Register. While the FDA has cleared several mass spec-based IVDs, including assays for screening newborns, metabolic diseases, and microbes in human cultures, it has yet to clear or approve an LC/MS-based test which measures proteins or peptides. Several LC/MS-based assays are available as laboratory developed tests (LDTs), which the FDA is planning to regulate as medical devices.

The FDA framed the workshop as an opportunity to engage the clinical LC/MS community with regards to the development and validation of LC/MS-based devices, and to work toward developing guidelines for review that will be "useful and relevant to both FDA and manufacturers." It will consist of oral presentations, followed by interactive panel discussions. Topics for the discussions include identifying pre-analytical and analytical variables that affect precision and reproducibility; defining methods of normalization, harmonization, and the use of internal standards for quantitation and device calibration; developing quality control materials; and identifying appropriate reference materials and predicate devices.

Registration for the workshop is available through the FDA's Workshops & Conferences Calendar.

Parties may submit electronic comments via the FDA's eRulemaking portal and written comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The FDA said it will select and notify participants by April 24.