Mike Stankiewicz, Bloomberg BNA: July 10, 2017
More than one thousand medical devices, including umbilical clamps, menstrual cups, and dentures, will be exempt from an FDA clearance process.The Food and Drug Administration removed 510(k) notification requirements for some moderate-risk devices under steps established by the 21st Century Cures Act ( Pub. L. No. 114-255), a 2016 law intended to speed new drugs and devices to the market and reduce regulatory burdens. The newly exempt devices include commonly used items like dentures, menstrual cups and scented menstrual pads, umbilical clamps, and certain hearing aids. […]
The 21st Century Cures Act requires the FDA to determine which class II devices no longer require the premarket clearance.The FDA said the exemption will help industry by eliminating costs and time required to comply with regulations. […]
Industry, Consumer Reactions
The Advanced Medical Technology Association, a medical device industry group, praised the FDA’s move.
“This action supports a risk-based review process for identifying lower-risk, well-established products for exemption and allows FDA to better focus its review resources to support the public health,” Janet Trunzo, senior executive vice president of technology and regulatory affairs at AdvaMed, told Bloomberg BNA July 10.
But Diana Zuckerman, president of the National Center for Health Research, a Washington-based nonprofit, said the FDA is going in the wrong direction because patients could be hurt by the moderate-risk devices.
“In addition to risks to patients, these FDA actions mean even less information about the devices that will be available to doctors and their patients,” she told Bloomberg BNA July 10. “How can doctors and patients make informed medical decisions without any any public information about these products? And how can medical care in the U.S. be made more affordable without requiring scientific evidence about safety or effectiveness for treatments that physicians are choosing for their patients?” […]
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