In a letter to FDA Commissioner Margaret A. Hamburg, Senator Chuck Grassley (R-Iowa) asked 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.
Stating that the inquiry follows up on questions he posed to the FDA more than a year ago after a ring used in heart-valve repair was being implanted in patients even though the device hadn’t been cleared for this purpose, Grassley noted that he would “appreciate a response to the requests set forth in this letter by no later than March 2.”
“My questions are aimed at establishing greater transparency and accountability for doctors and their patients,” Grassley said. “People have a right to know exactly what the FDA has approved, or not, in making decisions about their healthcare. 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.”
Grassley posed the questions:
- Would a manufacturer be required to update its device listings even if it changed only the name of an existing device?
- 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?
- 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.