The Food and Drug Administration (FDA) is announcing a public workshop entitled “Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.” 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.
- Date, Time and Location
- Federal Register Notice
- Registration
- Contact Us
Date, Time and Location
This meeting will be 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
- FDA Campus Information
The meeting will be webcast and the webcast link will be posted on this web page after April 25, 2016.
Registration to Attend the Workshop
If you wish to attend this Workshop, you must register by 4:00 p.m. on April 22, 2016.
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. FDA will do its best to accommodate requests to speak.
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, [email protected].
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: [email protected].