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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
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
The FDA has warned users of a vulnerability in Illumina’s genetic sequencing devices that could allow an authorized user to make changes to data from the devices. Read More
To help device manufacturers avoid the most common reasons for delays in technical documentation reviews — incomplete submissions and a lack of cohesive structure — the nonprofit European Association of Medical Devices Notified Bodies (dubbed Team NB) has published a compilation of guidance from many notified bodies in a set of best practices. Read More
Medtronic has cleared its slate of FDA objections to quality issues at its Northridge, Calif., diabetes headquarters, receiving a closeout notice from the agency to a warning letter issued in December 2021. Read More
Makers of connected medical devices should brace themselves for more FDA enforcement — warning letters, inspections, demands for information and untitled letters — as the digital health space unfolds and evolves, says a former Justice Department prosecutor. Read More
The FDA has deemed Avanos Medical’s Feb. 22 recall of certain Ballard Access closed suction ventilation devices as Class I, the most serious type of recall, as using these devices may cause serious injury or death. Read More
The FDA has deemed Fresenius Kabi’s March 8 recall of its Ivenix Infusion System as Class I, the most serious type of recall, as use of the device may cause serious injuries or death. Read More
The FDA would like to have the regulatory authority to restrict new opioid approvals to those that are safer than already-approved and marketed opioids, Commissioner Robert Califf told senators at a hearing discussing the agency’s 2024 budget request. Read More
The FDA has slapped Abbott Point of Care Canada with a warning letter for marketing a product with design and component changes without applying to the agency for clearance or approval. Read More