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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 FDA’s notice about the devices will be published July 11 in the Federal Register (FDA-2017-N-1129) and takes effect upon publication.The notice exempts 1,003 class II devices the FDA “believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness,” Bryce Bennett, regulatory counsel at the FDA, told Bloomberg BNA July 10. The FDA also told device owners that devices that have already been submitted for screening but are now exempt should be withdrawn. A 510(k) clearance allows a company to market a device that the FDA determines is equivalent to a predicate device already on the market. This pathway is used for most medical devices that reach the U.S. market.
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. The device industry is financially responsible for preparing device documentation and data for the FDA including 510(k) submission user fees.“These exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation,” the notice said. The action is also expected to decrease the FDA’s workload by reducing the amount of devices that need to be evaluated.In April, the FDA removed the premarket notification process from several dozen lower-risk, class I devices including patient restraints, first-aid kits, and dental syringes. Class I is the lowest risk classification for devices.
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?”
Trunzo, with the industry group, said manufacturers of these devices “still have extensive responsibilities under the [Federal Food, Drug, and Cosmetic Act] and their devices and diagnostics are subject to regulatory requirements including quality system and Medical Device Reporting.”
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The unpublished version of the FDA notice is at http://src.bna.com/qDo.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
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