MAKE YOUR VOICES HEARD at the Town Hall discussion with the director of the FDA’s Center for Devices and Radiological Health (CDRH) September 22nd, 2011.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.
Date, Time and Location
The meeting will be held on September 22, 2011, from 8:00 a.m. – 12:00 noon PDT, at the following location:
The Embassy Suites Hotel, San Francisco Airport
250 Gateway Boulevard
South San Francisco, CA 94080
(650) 589-3400
The meeting will not 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 planed three more this year. In March 2011, the meeting was held in Dallas, TX, and in May it was held in Orlando, FL. CDRH plans to host this final meeting of FY2011 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 2011 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 2011 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.
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.
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)
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.
Registration requests must be received by 5 p.m. EDT on Friday, September 9, 2011.
