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Jenis, Louis G. M.D. Response Letter 4/6/12

The Boston Spine Group

299 Washington Street, Newton, MA 02458

Louis G. Jenis. MD
Orthopaedic Spine Surgeon
Associate Clinical Professor
Orthopaedic Surgery
Tufts University School of Medicine

Fax: 617.219.6366

Attention: Linda D. Godfrey
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Bioresearch Monitoring
10903 New Hampshire Avenue
Building 66, Room 3462
Silver Spring, Maryland 20993-0002

April 6, 2012

Re: CTS# G060020/E004

Dear Ms. Godfrey:

This letter is written in response to the above-referenced warning letter received by The Boston Spine Group (''TBSG") medical offices located in Newton, Massachusetts, on February 15, 2012.1 We have carefully reviewed the letter and we want to assure you that we take the letter and the concerns expressed by the Food and Drug Administration ("FDA" or "Agency") very seriously. We are fully committed to working with the FDA to address the Agency's concerns and to ensure compliance with the applicable regulatory requirements.

Toward that end, we have taken immediate and significant steps to address the concerns expressed in the letter and to implement significant and substantial quality improvements to our program. We have engaged an expert consulting firm, The FDA Group,2 and expert FDA counsel,3 to assist us in responding to the warning letter and in implementing comprehensive and appropriate corrective actions and continuing quality improvements. As you are aware, the clinical trial is closed to new patients.4 In addition, beyond this trial, going forward, and based on careful consideration of our immediate medical goals, we do not plan to serve as clinical investigators in FDA regulated investigational device clinical trials involving human subjects for the foreseeable future, during which time we will be implementing the continuous quality improvements discussed in this response. At this time, we believe we can best serve patients in medical need through a robust medical practice, which affords us the opportunity to exercise more control over process that is currently available through sponsors, and through other forms of research (e.g., publication).

Nevertheless, we are fully committed to addressing the FDA's concerns in a comprehensive manner that reflects our commitment to robust regulatory compliance. In this regard, we are currently implementing significant quality improvements, including fully updated and/or revised SOPs and robust training, to address the issues and concerns expressed by the FDA. Accordingly, please find below our detailed response
to the warning letter. For ease of reference, each of the items listed in the letter are restated in bold italic text, followed by TBSG's written response. Our response explains the specific quality improvement program and strategies for corrective and preventive action. We believe these responses address the FDA's concerns in a robust manner.

We look forward to working with the FDA to address and resolve these issues and to the closure of this matter. Should you have any questions, please contact me.


Respectfully submitted,


Louis G. Jenis, M.D.

The Boston Spine Group


1 We very much appreciate your providing us an extension of time to Friday, April 6, 2012, to submit this response.

2 The FDA Group is a group of quality and regulatory compliance consultants with significant experience in medical device/diagnostics, pharmaceutical, biotechnology, and food matters regulated by the FDA, including inspections, compliance audits, and FDA Form 483 and warning letter assistance.

3 James S. Cohen, Esq., is a partner and the Head of the FDA Practice at the nationally recognized law firm McDermott Will & Emery LLP. Mr. Cohen served for over 17 years in senior legal and compliance positions at the FDA, including as Associate Chief Counsel, and as Deputy Director and Acting Director of the Office of Compliance and Biologics Quality, CBER, FDA. Mr. Cohen is a nationally recognized expert on FDA compliance and enforcement matters, including extensive experience in FDA bioresearch monitoring and clinical trial oversight at FDA and in private practice.

4 There are ten patients remaining on limited annual follow-up.