The U.S. Food and Drug Administration is defending a decision to accept more than 1,000 patient injury reports from Medtronic in summary form, years after they were supposed to be submitted.
The FDA responded earlier this month to questions from U.S. Sen. Al Franken of Minnesota by saying it took no action against Medtronic for the late reporting of a study of its Infuse bone graft because the information was consistent with data the agency already had.
