More than 1,000 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 notice, which took effect July 11, 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FDA also told device owners that devices that have already been submitted for screening but are now exempt should be withdrawn.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.
A medical device industry group praised the FDA’s move, but not everyone was happy.
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