This week, Senator Charles Grassley (R-IA), ranking member of the Senate Finance Committee, issued a press release asking the Food and Drug Administration (FDA) for accounting of its work to clarify approval status for medical devices.
In his letter, he specifically asked the FDA for an update on the implementation of new guidelines for medical device makers on when they need to file new information with the agency and seek clearance for the marketing and use of modified devices under the 510(k) system, the agency’s less stringent process for reviewing most medical devices.
His questions also concerned FDA’s requirements for manufacturers to report changes made to FDA-approved devices.
According to his letter, the cause for his concern came from “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.” Although today, that device, the Myxo dETlogix Annuloplasty Ring (dETlogix ring), has since been cleared by the FDA, Mr. Grassley was concerned about how the product was being implanted for more than two years on patients at Northwestern Memorial Hospital before a 510(k) was submitted to the Agency.
Accordingly, Senator Grassley wanted to know of 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,” since four months had passed without any response to his initial letter. He also cited information regarding device registration information listed on the FDA’s website and asked 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?
He asked FDA Commissioner Margaret Hamberg to respond no later than March 2, 2010. We will follow up on this article with their response, and changes made to the guidance.
Northwestern University HSPP Policy Manual
Northwestern University to Senator Grassley’s September 30, 2009 letter