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Medical Devices

Public Workshop - Clinical Flow Cytometry in Hematologic Malignancies, February 25-26, 2013

The purpose of this public workshop is to seek input from academia, Government, laboratorians, industry, clinicians, patients and other stakeholders on the role of clinical flow cytometry in hematologic malignancies, in order to develop a specific regulatory policy for this class of in vitro diagnostic devices.

Date, Time and Location

This meeting was held February 25 and 26, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue,
Building 31, Conference Center (Great Room 1503)
Silver Spring, MD 20993

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February 25

February 26

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Topics for discussion during this workshop include:

  1. Overview of Quality control and standardization issues associated with Clinical Flow Cytometry (FCM), including discussion of a NIST traceable standard;
  2. Biological controls in Clinical FCM: the use of stabilized whole blood samples and cryopreserved cells for normals and chronic lymphocytic leukemia (CLL);
  3. Third-party flow cytometry data analysis software; and
  4. Overview of FDA regulation of Clinical FCM using the 510(k) clearance process.

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8:00-8:05 amWelcomeGerald Marti, MD, PhD
8:05-8:10 amIntroductionMaria Chan, PhD
8:10-8:30 amOverview of FDA Device RegulationKevin Maher, PhD

Session 1:  Analytical Challenges in Standardization and Validation of FCM

8:30-9:00 amJoint NIST ISAC Standardization Framework for Quantitative Flow CytometryLili Wang, PhD
9:00-9:30 amNIAID NIH Nature Protocol for Quality Assurance for Multicolor FCM Using a Suite of Calibration BeadsStephen P. Perfetto, MS MT (ASCP)
9:30-10:00 amMulticolor Bead Flow Cytometry Standardization Heba Degheidy, MD, PhD,
10:00-10:30 amBreak  
10:30-11:00 amUK NEQAS Proficiency Testing in Acute and Chronic LeukemiasDavid Barnett, PhD
11:00-11:30 amBackground on College of American Pathologists (CAP) Proficiency Testing for Leukemia/LymphomaEric Hsi, MD
11:30 am-12:30 pmLunch 

Session 2:  Transitioning from Analytical to Clinical QC in FCM

12:30-1:00 pmThe Role of Biomarkers in Clinical Trials and the Fit-for-Purpose Method Validation Approach / Flow Cytometry Validation for Drug Development InstrumentsVirginia Litwin, PhD, Cherie Green, BS
1:00-1:30 pmLDTs in Flow Cytometry:  ICSH/ICCS Guidelines for Validation of Fluorescent Cell-based Diagnostic TestingTeri Oldaker, MLS, (ASCP), QCYM
1:30-2:00 pmFlow Cytometric Diagnosis of Low Grade B-cell Leukemia/LymphomaMaryalice Stetler-Stevenson, MD, PhD
2:00-2:30 pmBreak 
2:30-3:30 pmPublic Comment SessionShyam Kalavar, Moderator
3:30-4:30 pmPanel Discussion:  Virginia Litwin, PhD; Teri Oldaker; Stephen Perfetto; Maryalice Stetler-Stevenson, MD, PhDLea Carrington, Moderator
4:30-5:00 pmWrap Up Summary and Adjourn for the DayTremel Faison, MS, RAC, SCT (ASCP)

Session 3:  Clinical Diagnostic Flow Cytometry

8:00-8:15 amWelcome and Summary of Previous DayTremel Faison, MS, RAC, SCT (ASCP)
8:15-8:45 amBethesda Consensus Conference on Clinical Flow Cytometry of Hematolymphoid MalignanciesBrent Wood, MD, PhD
8:45-9:15 amEuroflow: Standardization, Monoclonal Antibody Selection and Panel ConfigurationTomas Kalina, MD, PhD  
9:15-9:45 amDifferent Approaches to Harmonisation and Standardisation - Experience from ERIC, EMN, Euroflow and ESCCAAndy C. Rawstron, PhD
9:45-10:15 amBreak 
10:15-10:45 amA Model for Harmonizing Flow Cytometry in Clinical Trials – The HIPC Lyoplate ExperiencePhillip McCoy, PhD
10:45-11:45 amPanel Discussion:  David Barnett, PhD; Robert Becker, MD, PhD; Raul Braylan, MD; Tomas Kalina, MD, PhD; Brent Wood, MD, PhDJennifer Dickey, Moderator
11:45 am-12:45 pmLunch 

Session 4:  Flow Cytometry Data Analysis Software

12:45-1:15 pmPerspective on Software Pitfalls and ChallengesBrent Wood, MD, PhD
1:15-2:15 pmPublic Comment Session 
2:15-2:45 pmBreak 
2:45-3:45 pmPanel Discussion:   Michael Borowitz, MD, PhD; Raul Braylan, MD; Maryalice Stetler-Stevenson, MD, PhD; Brent Wood, MD, PhDNicholas Anderson, Moderator
3:45-4:30 pmWrap-up Summary and Adjourn the MeetingMaria Chan, PhD

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Public Comment

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. You should also identify which discussion topic you wish to address in your comments. In order to keep each open public comment session focused on the discussion topic at hand, each comment should address only one discussion topic. FDA will do its best to accommodate requests to speak.

In order to obtain public comment, FDA is also soliciting either electronic or written comments on the issues discussed. The deadline for submitting comments is by 5 p.m. on April 1, 2013. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to

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Contact Us

For questions regarding workshop content please contact:

Carol Krueger
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, rm. 5437
Silver Spring, MD 20993-0002
Phone: 301-796-3241

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