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Letter to FDA from consumer groups with recommendations for medical device

March 21, 2011

Helene Clayton-Jeter, OD and Malcolm Bertoni, MS
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Re: Medical Device User Fee Act Stakeholder Meetings

Dear Dr. Clayton-Jeter and Mr. Bertoni:

As members of the Patient, Consumer, and Public Health Coalition, which includes nonprofit organizations and individuals that represent patients, consumers, scientists, and researchers, we thank you for all of your efforts to make the MDUFA meetings truly interactive. We greatly appreciated the way the February 16, 2011 meeting, which focused on MDUFA performance and medical device pre-market review, was conducted. Allowing stakeholders to ask questions during the presentations not only clarified issues but also gave individual organizations and coalitions another opportunity to voice their concerns about MDUFA issues. We recommend that you keep this format, or at least include time for comments after each presentation, followed by a discussion between stakeholders and the FDA.

We also thank you for soliciting stakeholders’ priorities at the January 13th meeting on Medical Device User Fees (MDUFA) and we request that you select topics that are most relevant to the MDUFA negotiations and reauthorization process. Our coalition is particularly interested in discussing the following issues:

• Implementing stricter standards for reviewing medical devices that ensure that science informs all device reviews.

• Implementing post-market surveillance/studies when needed to ensure safety of 510(k) cleared devices.

• Rescinding clearance of a recalled 510(k), and ensuring that a recalled device cannot be used as a predicate.

• Requiring that devices that were cleared as substantially equivalent to a device that is subsequently recalled must be re-submitted for clearance.

• Inspecting manufacturing plants as part of the 510(k) process in order to avoid manufacturing problems.

• Establishing a data registry and unique identifying numbers to track medical devices, especially implantable devices.

The above are our preliminary MDUFA suggestions to improve the agency’s performance in terms of ensuring that consumers have access to safe and effective medical devices, and to guarantee the scientific integrity of the safety review process. As the MDUFA stakeholders meeting progress and we hear more from FDA staff about your ideas, we may refine these and also develop additional recommendations. We look forward to participating in the upcoming meetings.


Breast Cancer Action
Center for Medical Consumers
Consumers Union
Government Accountability Project
Institute for Ethics and Emerging Technologies
National Consumers League
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
National Women’s Health Network
Our Bodies Ourselves
The TMJ Association, Ltd.
Truth in Medicine Incorporated
Union of Concerned Scientists, Scientific Integrity Program
Woody Matters

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