Dear Commissioner Hamburg:
The United States Senate Committee on Finance (Committee) has jurisdiction over, among other things, the Medicare and Medicaid programs. As Ranking Member of the Committee, I have a responsibility to the more than 100 million Americans who receive health care coverage under these programs to oversee their proper administration and ensure that taxpayer dollars are appropriately spent on safe and effective drugs and devices.
I appreciate your response of Sept. 30, 2009, to my questions regarding the Food and Drug Administration’s (FDA or Agency) guidance to manufacturers on when a modification to a device requires the filing of a new 510(k). Over a year ago, I wrote to the FDA regarding serious allegations that an annuloplasty ring used in heart valve repair was being implanted in patients even though the device was allegedly not cleared for marketing by the FDA. The FDA concluded that the company had made the wrong decision when it marketed the product without first seeking clearance from the Agency. That device, the Myxo dETlogix Annuloplasty Ring (dETlogix ring), has since been cleared by the FDA, but as I stated in my letter to the FDA last April, the fact remains that for more than two years, patients at Northwestern Memorial Hospital were being implanted with the device before a 510(k) was submitted to the Agency.
I also wrote to Northwestern Memorial Healthcare and Northwestern University in September regarding the same allegations and asked them whether or not they obtain assurances or confirmation from a device manufacturer that a device is FDA-approved before it is used in their facilities. Attached are their responses for your consideration. Northwestern Memorial Healthcare stated in its response that Edwards Lifesciences assured Dr. McCarthy that it was taking the steps necessary for FDA approval. It also stated that, “the health care provider relies on the manufacturer to provide timely and accurate information regarding the regulatory status of the device." However, in this case, the manufacturer followed FDA's guidance and made the wrong decision regarding its device.
In your September response, you stated that FDA believes its current policy on when a modification to a device requires a new 510(k) submission is not sufficiently clear and is revising the guidance document. I agree that the guidance document needs to be revised so that we can prevent similar events from occurring in the future. However, it has been more than four months since I received your response and the new guidance has yet to be released. Accordingly, I would appreciate you advising me immediately on the status of FDA’s revisions to the Agency’s guidance entitled, “Deciding When to Submit a 510(k) for a Change to an Existing Device."
In addition, it is my understanding that device manufacturers registered with the FDA must also list the devices that they make with the Agency. According to FDA’s website, registration information must be submitted each year between October 1 and December 31 eve if no changes have occurred, and at that time listing information should be reviewed as well.
The website also states that a manufacturer can access the FDA Unified Registration and Listing System at any time to update changes to their registration and listing information as the changes occur. Examples provided by the FDA include a change to a previously listed device or the introduction of another device into commercial distribution. In light of the statements made on FDA's website please respond to the following questions:
1) Would a manufacturer be required to update its device listings even if it changed only the name of an existing device?
2) Would the manufacturer also be required to update its listings if it made a modification to a device that did not require submission of a new 510(k) but marketed that device under a different name?
3) If the answer to either question is no, please explain why not. Please also explain how patients and their doctors would obtain information about the status of a device other than from the manufacturer itself.
4) FDA concluded that Edwards Lifesciences’ dETlogix ring did require a new 510(k).
However, even if a new 510(k) had not been required, was the company required to list that device with the FDA?
Thank you for your attention to this important matter. I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.
Sincerely,
Chuck Grassley United States Senator Ranking Member of the Committee on Finance
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