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
• Federal Register Notice
• Webcast
• Transcripts
• Topics
• Agenda
• Public Comment
• Contact Us

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

• Link for FDA Campus Information

Webcast

February 25

• Webcast Part 1
• Webcast Part 2
• Webcast Part 3
• Webcast Part 4

February 26

• Webcast Part 5
• Webcast Part 6
• Webcast Part 7
• Webcast Part 8

Transcripts

• Transcript for February 25th
• Transcript for February 26th

Topics

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.

Agenda

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 http://www.regulations.gov.

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
email: Carol.Krueger@fda.hhs.gov