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Congress granted the FDA new authority under the Food and Drug Omnibus Reform Act of 2022 to ban a medical device for one or more intended uses, but it remains to be seen how the agency will use the new enforcement tool, according to Washington, D.C.-based attorney John Claud of the law firm Hyman, Phelps & McNamara. Read More
Over the past week, the FDA issued several guidance documents — including a final guidance on developing nicotine replacement therapy drug products, a final guidance on quality risk management and a draft guidance on decentralized clinical trials for drugs, biological products and devices. Read More
There is no other cleared device that can allow fully paralyzed or locked-in patients to communicate once eye-tracking is no longer possible for the patient, the company said. Read More
Devicemakers and equipment servicing companies are locked in a battle over the idea of “right to repair,” debating whether third-party repair companies should be federally regulated in the same way device original equipment manufacturers (OEM) are. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
New digital technologies that enable clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT). Read More
The FDA’s Breakthrough Device program, launched in 2018 to meet two agency aims — encouraging innovative devices in areas of greatest need and bringing them to market more quickly — has so far achieved only one. The “fast track” to patient availability has not materialized, regulatory experts say. Read More
As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
The UK plans to extend its acceptance of CE-marked devices through at least 2028, pushing back the current June 30 deadline for devices to comply with the UK’s post-Brexit equivalent. Read More