The U.S. Food and Drug Administration and the $110 billion medical device industry held a series of private meetings earlier this year to jointly craft a major bill that loosens—wait for it—medical device regulations.
While lobbyists helping write legislation isn’t particularly new, the level of cooperation between regulator and regulated on the 21st Century Cures bill, revealed in recently released agency documents, has earned the scorn of some consumer groups. The law, passed by the House of Representatives, would make it easier for devices to reach the market and put safety determinations in the hands of subcontractors paid by device manufacturers.
