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Medical Devices

Array-Based Cytogenetic Tests: Questions on Performance Evaluation, Result Reporting and Interpretation, June 30, 2010

The purpose of the meeting is to seek input on challenges related to performance evaluation, determination of clinical significance, result reporting and interpretation for array-based cytogenetic tests.

Date, Time and Location

This meeting will be held June 30, 2010, beginning at 1:30 pm, at the following location:

Hyatt Regency Bethesda
7400 Wisconsin Avenue
Bethesda, MD 20814

The meeting will not be videotaped or webcasted.

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Tentative Agenda

1:00 pmRegistration
1:30 pmFDA Welcome
1:35 pmBackground
2:00 pmPanel Discussion
4:30 pmPublic Comments
5:00 pmMeeting Adjourns

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Registration to Attend the Workshop

Registration is closed as of June 21, 2010.

If you wished to make an oral presentation during the open comment session at the meeting, you must have indicated this at the time of registration. FDA requests that presentations focus on the areas defined in section III of this document. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep open session focused, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

If you need special accommodations due to a disability, or additional information regarding registration, please contact Susan Monahan, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 66, Rm 4321, Silver Spring, MD 20993, 301-796-5661, e-mail:; or Zivana Tezak, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 66, Rm 5668, Silver Spring, MD 20993, 301-796-6206, e-mail at least 7 days in advance. 

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Contact Us

Susan Monahan
Food and Drug Administration
10903 New Hampshire Ave, Bldg 66, Rm 4321
Silver Spring, MD 20993
Phone: 301-796-5661

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