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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
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
The FDA requires devicemakers to verify that a product meets each of its design specifications, which is generally accomplished through postproduction inspection or testing. Read More
Takeda has another shot on goal for a self-administered subcutaneous form of its blockbuster Entyvio (vedolizumab) as maintenance treatment for patients with ulcerative colitis who have completed induction therapy with the antibody’s intravenous form. 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
Over the past week, the FDA issued an authorization of a medical device, a request for comments for a public workshop and proposed data and information collections. Read More
Significantly modifying its Velopex Aquacut fluid abrasion unit in multiple ways without submitting a new 510(k) clearance application has resulted in the UK’s Medivance Instruments receiving a Feb. 13 warning letter from the FDA. 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