Chris, and others, have encouraged me to put up some contact information in regards to DTC testing and the . Here is what Chris has gathered....
The Center for Devices and Radiological Health (CDRH) is the division of the FDA that would be responsible for DTC genetic testing. And Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) is the relevant CDRH office. The CDRH director is Jeffrey Shuren. OVID's director is Alberto Gutierrez, and OVID's personalized medicine staff are headed by Elizabeth Mansfield. Use the following to contact FDA staff: • list of CDRH personnel • contact info search form. Dr. Jeffrey Shuren Director, CDRH White Oak Office Building 66 10903 New Hampshire Avenue Silver Spring MD 20993 Phone 301-796-5900 Fax 301-847-8510 jeff.shuren@fda.hhs.gov Nancy Stade Deputy Director for Policy, CDRH White Oak Office Building 66 10903 New Hampshire Avenue Silver Spring MD 20993 Phone 301-796-5900 Fax 301-847-8510 nancy.stade@fda.hhs.gov Alberto Gutierrez Director of OVID White Oak Office Building 66 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone 301-796-5453 Fax 301-847-8515 alberto.gutierrez@fda.hhs.gov Elizabeth Mansfield Director of Personalized Medicine White Oak Office Building 66 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone 301-796-4664 elizabeth.mansfield@fda.hhs.gov The Commissioner of the Food and Drug Administration is Dr. Margaret Hamburg. She's probably busy, but her chief of staff is Molly Muldoon. There is a list of the commissioner's closest staff here and an address search form here. Dr. Margaret Hamburg Commissioner of the FDA White Oak Office Building 1 10903 New Hampshire Avenue Silver Spring MD 20993 margaret.hamburg@fda.hhs.gov Molly Muldoon Chief of Staff, FDA White Oak Office Building 1 10903 New Hampshire Avenue Silver Spring MD 20993 Phone 301-796-9691 molly.muldoon@fda.hhs.gov
More at Chris' post.
