FDA exempts 120 devices from 510(k) clearance requirements

The FDA said it will not enforce 510(k) clearance regulations on 120 low-risk classes of devices, making life easier for the device industry. And cheaper. A 510(k) application costs about $5,000 on average. The move to exempt low-risk devices from regulations was called for by Congress in the 2012 Medical Device User Fee Act. The devices are listed in the document announcing the policy shift, which finalizes a draft guidance issued in August. Devices to be exempted include things like trocars, lung sound monitors, denture pads, simple hearing aids, first aid kits, menstrual cups, bath paraffin, surgical drapes, water-filled teething rings and the like. For now the agency will simply ignore the regulations on those devices using its "enforcement discretion." Formal exemption via the notice and ruling making process will occur eventually. Read the guidance (PDF) | here is RAPS' take

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