Shuren correspondence with Edwards

Vikas Kumar filed this request with the Food and Drug Administration of the United States of America.
Tracking #


Est. Completion None
No Responsive Documents


From: Brandon Smith

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

Any and all correspondence between FDA staff member Jeffrey E. Shuren, and 1. Edwards Lifesciences, and 2. Patrick M. McCarthy, over the date range January 1, 2008 to December 31, 2012. This includes written letters, emails to/from the staff member’s FDA account, and emails to/from the staff member’s personal emails account(s). (FOIA applies to personal accounts if the business being conducted is public business, and any communication between a device manufacturer and a device-approval administrator at FDA is, likely by definition, public business.)

The requested documents will be made available to the general public, and this request is not being made for commercial purposes. The requester is a journalist working for a Congressionally-accredited periodical.

If you intend to acknowledge receipt of this request or give me an internal tracking number, please do so via the same means used to communicate this request to you. (For instance, a reply to the original email.)

We would prefer that any questions about the request be asked via the same communication method. However, if you need to explain or ask something complicated, you may call us at 202-813-1032, extension 120. We will memorialize phone conversations via email afterward.

In the event that there are fees, please inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically--by e-mail attachment, or if the response is too large, direct download link or mailed CD-ROM.

If mailing a CD, please alert us of this fact via reply email (so we know to wait on the post), and send the CD to:

c/o Brandon Smith
The Capitol Forum
1233 20th St NW #301
Washington, DC 20036

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.


Brandon Smith
The Capitol Forum

From: Food and Drug Administration

Brandon Smith
The Capitol Forum
1233 20th St NW #301
Washington, DC 20036

DEPT MR 37354
411A Highland Ave
Somerville, MA 02144-2516

Dear Brandon Smith,

Your FOIA Request No. 2017-4214 has been completed. Please see the files I have attached.

Julia D. Drake
Government Information Specialist
Division of Information Disclosure (DID)
Office of Communication & Education (OCE)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration
Tel: 240-402-6495
WO Building 32, Office No. 4217
10903 New Hampshire Ave
Silver Spring, MD 20993<>

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