House Committee Advances User Fees With Full Slate Of Device Amendments
House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.
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At a recent industry briefing to educate US congressional members about proposed legislation to mandate registration with FDA and reporting requirements for third-party servicers of devices, an equipment servicing company said a major downside of H.R. 2112 would be the burdens of having to register with both his business' home state and the federal agency, and that his firm and others already report adverse events to FDA.
The Medical Imaging Technology Alliance has pulled together a consensus body of original equipment manufacturers, third-party servicers and others to create voluntary quality management system standards for servicing advanced imaging and other medtech equipment, while stakeholders look ahead to an FDA third-party servicing report due in May.
The Senate Aug. 3 swiftly approved the FDA Reauthorization Act (FDARA) on a 94-1 vote. The president is expected to sign the bill, which previously passed the House and will enact the MDUFA IV user-fee agreement and make reforms tied to device accessory review, device facility inspections, and medical imaging FDA reviews.