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  5. Michael Ring, MD - Close Out Letter 1/6/15
  1. Warning Letters

CLOSEOUT LETTER

Michael Ring, MD


Michael Ring, MD

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

January 6, 2015


Michael Ring, MD
122 W. 7th Avenue
Suite 232
Spokane, WA 99204-2349


Dear Dr. Ring

The purpose of this letter is to acknowledge receipt of your letter and attachments dated November 20, 2014. In your letter, you provided information regarding the corrective/preventive actions taken in response to the Information Letter that was issued to you on September 30, 2014. This Information Letter was issued to you after an inspection of your clinical site conducted from June 23, 2014 to July 2, 2014 by an investigator from the FDA’s Seattle District Office.

Your current letter includes actions you have taken prior to the FDA inspection as well as those responding to the Information Letter items. These actions include:
 

1) Documentation that three subjects were reconsented.
2) A revision to the SOP indicating that the clinical investigator will sign the consent form prior to any research intervention.
3) A revision to the SOP describing Sponsor/CRO Communications that reinforces the accountability of the CI in the research.
 

We have evaluated the information you sent and your proposed corrective action plan, and we find that your response appears to be adequate. Implementation and execution of the corrective actions provided in your letter should assist you in avoiding recurrence of the issues observed. Your corrective actions may be verified during a future inspection. No response to this letter is necessary

For information concerning the Bioresearch Monitoring program, please visit our Internet homepage at http://www.fda.gov/cdrh/comp/bimo.html. The Division of Bioresearch Monitoring has developed introductory training modules in FDA-regulated device clinical research practices, which are available on the FDA website. The modules are for persons involved in FDA regulated device clinical research activities. These modules are located at the following website address: http://www.fda.gov/Training/CDRHLearn/ucm162015.htm.

If you have any questions, you may contact Carol Simmons at 301-796-5956, or by mail at the following address:

 

Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Bioresearch Monitoring
10903 New Hampshire Avenue
Building 66 Room 3506
Silver Spring, Maryland 20993-0002

 

Sincerely yours,

/S/

Adam Donat, MS
Chief, Bioresearch Compliance Branch II
Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and
   Radiological Health


cc:

Declan Dineen
Senior Manager, Regulatory Affairs
Medtronic CardioVascular
3576 Unocal Place
Santa Rosa, CA 95403

William Dittman Jr., MD, Co-Chair
Douglas Weeks, PhD, Co-Chair
Spokane IRB
Fifth & Browne Medical Center
104 W. Fifth Avenue
Suite 340W
Spokane, WA 99204