Medical Devices

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) announced a public workshop entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” The topics discussed were 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 was on the validation considerations with protein- and peptide-based LC/MS devices.


Date, Time and Location

This meeting was held May 2, 2016, from 8:30 a.m. – 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Agenda

Time
Title
Speaker
8:30-8:35WelcomeAlberto Gutierrez, Ph.D. (FDA)
8:35-8:45Purpose of the WorkshopJulia Lathrop, Ph.D. (FDA)
8:45-9:00Keynote: Using Mass Spectrometry to Help PatientsAndrew Hoofnagle, M.D., Ph.D. (U. Washington)

Session 1: Aspects of Protein/Peptide LC-MS

9:00-9:15Review of FDA Discussion PaperDoug Jeffery, Ph.D. (FDA)
9:15-9:30Creation through Curation: Empirical Peptide Selection and Digest OptimizationChristopher Shuford, Ph.D. (Laboratory Corporation of America)
9:30-9:45Aspects Of Affinity Enrichment For Quantification Of Proteins And Peptides By Mass SpectrometryJeff Whiteaker, Ph.D. (Fred Hutchinson Cancer Research Center)
9:45-10:00Selection and Use of Calibrators and Internal Standards for Quantitative ProteomicsMark Lowenthal, Ph.D. (National Institutes of Standards and Technology)
10:00-10:15QUESTIONS
10:15-10:30BREAK
10:30-10:45Skyline: A Community Platform for Targeted Assay Development and ExecutionJarrett Egertson, Ph.D. (U. Washington)
10:45-11:00Software Requirements For The Use Of Mass Spectrometers In Real World Clinical SettingsRandall Julian, Ph.D. (Indigo bioAutomation)
11:00-11:15FDA Overview of Instrumentation and Software ReviewAndrew Grove, Ph.D. (FDA)
11:15-11:30QUESTIONS
11:30-12:15PUBLIC COMMENTSKelly Oliner, Ph.D. (FDA)
moderator
12:15-1:15
LUNCH

Session 2: Aspects of FDA Regulatory Processes

1:15-1:30Overview of FDA Regulatory ProcessesJinong Li, Ph.D. (FDA)
1:30-1:45Overview of FDA Regulation of IDEsElaine Blyskun, B.Eng. (FDA)
1:45-2:00Overview of FDA review of Multiplexed/IVDMIA DevicesKellie Kelm, Ph.D. (FDA)
2:00-2:15How To Prepare A PresubmissionYvonne Shea, M.S. (FDA)
2:15-2:30QUESTIONS
2:30-2:45BREAK

Session 3: Panel Discussions

2:45-4:00

Outside Panel-MS In The Clinical Lab: Discussion Paper Questions

Lorin Bachmann, Ph.D. (Virginia Commonwealth University), Cory Bystrom, Ph.D. (Cleveland Heart Lab), Daniel Chan, Ph.D. (Johns Hopkins University), Russell Grant, Ph.D. (Laboratory Corporation of America), Andrew Hoofnagle, M.D., Ph.D. (U. Washington), Alan Rockwood, Ph.D. (ARUP Labs), Ravinder Singh, Ph.D. (Mayo Clinic), Victoria Zhang, Ph.D. (U. Rochester)

Julia Lathrop, Ph.D. (FDA)
moderator

4:00-4:15BREAK
4:15-4:50

FDA Panel: Questions Open To The Floor

Elaine Blyskun, B.Eng., Andrew Grove, Ph.D., Doug Jeffery, Ph.D., Kellie Kelm, Ph.D., Julia Lathrop, Ph.D., Joshua Levin, Ph.D., Donna Roscoe, Ph.D., Yvonne Shea, M.S.

Henry Rodriguez, Ph.D. (NIH/NCI)
moderator

4:50-5:00Wrap upLea Carrington, MBA, MS, MT(ASCP) (FDA)

Webcast Archive

Transcripts

Presentations

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO-32 Room 5231, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact:

Julia Tait Lathrop, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5614, Silver Spring, MD 20993, 240-402-5034, email: julia.lathrop@fda.hhs.gov.

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