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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service


                Food and Drug Administration
                 10903 New Hampshire Ave
                                                                                                                 Silver Spring, MD  20993
      
August 9, 2016
FOIA request #: 2015-4971

Ms. Trivedi Madhuri


1405 Rock Ridge Road
Waukesha, WI 53188

Dear Ms. Madhuri:

This letter is in response to your Freedom of Information Act (FOIA) request (copy attached)
dated June 19, 2015, and received by the Food and Drug Administration (FDA) on June 19,
2015. Your request asked for information for InsiteExc products that GE Healthcare was
shipping aging and defective products.

The Center for Devices and Radiological Health (CDRH) conducted a reasonable search of:

Image 2000+ and CTS

After a reasonable search, we located fifty six (56) pages of records responsive to your request.
Certain materials have been deleted from the records furnished to you because a preliminary
review of the records indicated the deleted information is not required to be publicly disclosed.

Portions of the records were withheld pursuant to exemption 5 of the FOIA. (5 U.S.C. 552
(b)(5)).

Exemption 5: Protects inter-agency or intra-agency memorandums or letters which would not be


available by law to a party other than an agency in litigation with the agency. The three most
frequently invoked privileges are the deliberative process privilege, attorney-client privilege, and
the attorney work-product doctrine. Here, we invoke the deliberative process privilege.

You have the right to appeal this determination. By filing an appeal, you preserve your rights
under FOIA and give the agency a chance to review and reconsider your request and the
agencys decision.
Your appeal must be mailed within 90 days from the date of this response, to:

Ms. Catherine Teti


Deputy Agency Chief FOIA Officer
U.S. Department of Health and Human Services
Office of the Assistant Secretary for Public Affairs
Room 729H
200 Independence Avenue, S.W.
Washington, DC 20201

Please clearly mark both the envelope and your letter Freedom of Information Act Appeal.
If you would like to discuss our response before filing an appeal to attempt to resolve your
dispute without going through the appeals process, please contact the Government Information
Specialist who processed this request at (301)796-9554 or by email at (Ted Gean
ted.gean@fda.hhs.gov). You may also contact the HHS FOIA Public Liaison for assistance at:

Michael Bell
HHS FOIA Public Liaison
U.S. Department of Health and Human Services
Office of the Assistant Secretary for Public Affairs
Room 729H
200 Independence Avenue, S.W.
Washington, DC 20201
Telephone: (202) 260-0793
E-mail: HHS_FOIA_Public_Liaison@hhs.gov

If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of
Government Information Services (OGIS), the Federal FOIA Ombudsmans office, offers
mediation services to help resolve disputes between FOIA requesters and Federal agencies. The
contact information for OGIS is:

Office of Government Information Services


National Archives and Records Administration
8601 Adelphi RoadOGIS
College Park, MD 20740-6001
Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-mail: ogis@nara.gov
Fax: 202-741-5769

X The following charges will be included in a monthly invoice:


Reproduction: $0.00 Search:$23.00 Review: $23.00 Other: $1.00 Total: $ 47.00

Sincerely,
Digitally signed by Latroy D. Tinch -S
Latroy D. DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=130011196
Tinch -S 7, cn=Latroy D. Tinch -S
Date: 2016.08.09 09:30:31 -04'00'

LaTroy Tinch
Branch Chief
Division of Information Disclosure
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration