The US Food and Drug Administration (FDA) has exempted more than 1,000 moderate-risk medical devices, including dentures and menstrual cups, from its clearance process under July 11. The legislation enables the FDA to clarify which Class II devices no longer require the premarket clearance. While some have hailed the decision, Diana Zuckerman, the president of non-profit organisation National Center for Health Research, warned that "patients could be hurt by the moderate-risk devices".
The US Food and Drug Administration (FDA) has exempted more than 1,000 moderate-risk medical devices, including dentures and menstrual cups, from its clearance process under the 21st Century Cures Act. The legislation enables the FDA to clarify which Class II devices no longer require the premarket clearance. While some have hailed the decision, Diana Zuckerman, the president of non-profit organisation National Center for Health Research, warned that "patients could be hurt by the moderate-risk devices".