Senator Charles Grassley (R-IA), Senate Finance Committee Ranking Member, has asked the U.S. Food and Drug Administration (FDA) for updates on new guidelines for medical device makers in the marketing and use of modified devices under the FDA's 510(k) system.

A year previously, Grassley says in his letter to the Agency, he had made inquiries to the FDA after news that the Myxo dETlogix Annuloplasty Ring (since cleared by the FDA) had been implanted in patients at the Northwestern Memorial Hospital before a 510(k) was submitted to the FDA. After Grassley's initial inquiry, the FDA had told the Senator it would be updating its policy.

"My questions are aimed at establishing greater transparency and accountability for doctors and their patients," Grassley said in a press release. "People have a right to know exactly what the FDA has approved, or not, in making decisions about their health care. For this to happen, the FDA's policies need to be effective in establishing an accurate public record about the FDA-approval status of any particular product."

In the letter, Grassley is asking four questions in light of the FDA policy that device manufacturers registered with the FDA must also list the devices that they make with the Agency; and that registration information must be submitted yearly even if no changes have occurred. Grassely's questions are:

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?

Senator Grassley has asked for a response by March 2, 2010.

Adapted in part from a press release from Senator Grassley.

Link to Senator Grassley's letter: http://finance.senate.gov/press/Gpress/2010/prg021710.pdf

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