INFORMATION UPDATE - ASHI’s Call to Action: Public Comment
FDA MAILING ADDRESS - UPDATED (listed below)
Dear ASHI Member:
On June 27th we notified you that the FDA recently published a DRAFT guidance document regarding Research Use Only/Investigational Use Only (RUO/IUO) products. We hope you have already submitted your comments through the FDA web site. If you have not, the DRAFT guidance document can be found here and the page for submission of comments can be accessed here. Deadline for public comment is August 29, 2011.
Since then, the ASHI Board of Directors has determined that the issue of proposed FDA oversight of laboratory developed tests (LDTs) has become so critical that more needs to be done. Thus, we are asking you to write to the FDA as well as your elected officials regarding this topic which is very important to our laboratories, transplant programs and patients. To assist you in this effort, ASHI has drafted the attached template that can be customized and sent to the FDA and/or your government official. The address for the FDA is on the letter, and links are listed below for locating the addresses of your government officials.
We urge you to please take the time to make your opinion heard.
Thank you,
Geof Land, ASHI President
Amy Hahn, ASHI President-Elect
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DOCUMENTS/LINKS
DOWNLOAD TEMPLATE
Customizable Template Letter
(updated 8/2/11)
Send FDA Letter to:
Alberto Gutierrez, Ph.D.
Director of OIVD
Food and Drug Administration
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
LOCATE SENATOR ADDRESS
http://www.senate.gov/general/contact_information/senators_cfm.cfm
LOCATE REPRESENTATIVE ADDRESS
http://www.house.gov/representatives/
(located top right next to map)
VIEW FDA DRAFT GUIDANCE DOCUMENT
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm253307.htm
TO SUBMIT COMMENT
http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0305-0001
If you have newsworthy information to add to the ASHI Web site, please contact kmiranda@ahint.com for consideration.