On June 7, 2017, the U.S. House of Representatives Energy and Commerce Committee approved an amendment to the FDA Reauthorization Act of 2017 which will require the FDA to submit to the House and Senate Committees a report on how the FDA intends to ensure the quality and continued effectiveness of devices with respect to servicing “performed by any entity engaged in servicing other than the manufacturer of the device. The amendment, if passed by the full House and Senate will require the FDA to report within 6 months on: (i) the specific activities performed on a device by the manufacturer of the device or other entities; (ii) a description of the legal authority of the FDA used to oversee and regulate servicing conducted with respect to the device; (iii) detail how the FDA intends to protect public health by ensuring consistent quality, safety and continued effectiveness of the devices;(iv) provide information on how the FDA can better understand the device servicing industry including the size, scope, location and composition of entities performing such servicing and the rate of adverse events related to such servicing; (v) address the current regulation by states, the Joint Commission or other regulatory bodies of servicing with respect to devices by all entities including manufacturers, third party entities and hospitals.
Independent servicers across the nation have registered with their congressional representatives strong disapproval to the proposed independent servicers legislation.
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The FDA Medical Device User Fee Amendments (MDUFA IV) package is heading to a Senate committee vote — and it appears not to include any of the House legislative language on independent servicer registration.
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