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Study: Harmful medical devices approved too easily
USA Today

Most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don’t require human testing, an analysis found. The report comes as the Food and Drug Administration is reviewing sweeping proposals to revise the medical device approval process. The studied devices fell under rules for products similar to ones on the market, not regulations for brand new ones, which call for more extensive testing.