Register for May 5th FDA, CDRH Townhall meeting by April 22nd

FDA

MAKE YOUR VOICES HEARD at the Town Hall discussion with the director of the FDA’s Center for Devices and Radiological Health (CDRH) May 5, 2011. You must register by April 22nd to be included. CDRH is the office within FDA that has failed to protect consumers by not making amalgam a class 3 device nor requiring amalgam manufacturers to prove safety.The deadline for online registration will be Friday, April 22.

Date, Time and Location

The meeting will be held on May 5, 2011, from 8:00 a.m. – 12:00 noon EST, at the following location:

Sheraton Orlando Downtown Hotel
400 West Livingston Street
Orlando, Florida 32801
Phone: (407) 843-6664

The meeting will not be videotaped or webcast.

Supplementary Information

Background

In 2010, CDRH held three Town Hall meetings in Minneapolis, Boston, and Los Angeles to provide the public with a new venue to discuss issues of interest with the Center. Due to positive feedback, we plan to hold three more this year. In March 2011, the meeting was held in Dallas, TX. After this meeting in Orlando, CDRH plans to host another in San Francisco, CA. The objective of this Town Hall meeting is to engage in a dialogue about issues that are of importance to the public.

Meeting Details

The meeting will open with an introduction of CDRH Senior Staff in attendance. Following introductions, Dr. Jeffrey Shuren, the Director of CDRH, will describe CDRH’s Strategic Priorities for 2011. Members of the public will then be given the opportunity to present comments to CDRH Senior Staff followed by Q&A session during which any member of the public may ask questions of the CDRH Senior Staff on any topic of interest.

Public Meeting

The objective of this public meeting is to present the Center for Devices and Radiological Health (CDRH) FY 2010 Priorities. In addition, FDA is interested in engaging in discussions about issues that are of importance to the medical device community. CDRH wishes to obtain feedback/ideas for facilitating two-way communication between CDRH and the medical device industry.

The meeting will open with an introduction of CDRH Senior Staff in attendance. Following introductions, Dr. Jeffrey Shuren, the Director of CDRH, will present the FY 2010 CDRH Priorities. Next, industry representatives and other public citizens will be given the opportunity to present comments to CDRH Senior Staff. In addition, the attendees from CDRH will respond to questions presented by industry and other public citizens.

Hotel Information

Sheraton Orlando Downtown Hotel

Group Rate: Request the sleeping room block for the “Food and Drug Administration Town Hall Meeting”

Transcripts

Transcripts of the public meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public meeting at a cost of 10 cents per page.

A transcript of the public meeting will be available online.

Registration

The deadline for online registration will be Friday, April 22, 2011.

If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at [email protected] at least 7 days in advance of the meeting.

Meeting Agenda

8:00 a.m. Opening Remarks/Welcome:

Dr. Jeff Shuren, Director, CDRH, FDA

Public Presentations

Break

Question & Answer Session:

Dr. Jeff Shuren, Director, CDRH

Dr. Bill Maisel, Deputy Director for Science, CDRH

Ms. Christy Foreman, Office of Device Evaluation, CDRH

Dr. Alberto Gutierrez, Office of InVitro Diagnostics, CDRH

Mr. Steven Silverman, Office of Compliance, CDRH

12:00 p.m. Adjourn Public Meeting

12:15 p.m. Press Conference (in back of ballroom)

Contact Us

For further information about this meeting, contact: Heather Howell

Food and Drug Administration. Center for Devices and Radiological Health

10903 New Hampshire Avenue, Bldg. 66, rm. 4320

Silver Spring, MD 20993 – 301-796-5718

e-mail: [email protected]

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