Two members of congress called for the U.S. Food and Drug Administration to "overhaul and streamline" its recalls and 510(k) premarket notification databases, in a letter sent to Director Jeffrey Shuren, M.D., this week. Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) ask FDA to clarify on its 510(k) database not only devices have been recalled for flaws, but also when a device repeats a design flaw, iHealthBeat reported.
"Already, thousands of patients have been harmed--in some case grievously and irrevocably--by medical devices that were modeled after recalled devices," Markey and Merkley wrote. They requested that FDA officials respond to the letter by Sept. 19. Letter (.pdf)