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The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
The FDA will soon begin identifying candidates for a pilot program whereby manufacturers can opt to self-identify and correct possible regulatory violations and avoid FDA inspection. Read More
Sharplight Technologies, an Israeli maker of powered surgical lasers, received an FDA warning letter for failures with quality records and other documents. Read More
The UK’s National Institute for Health and Care Excellence has given a thumbs up to JOTEC’s heart device to treat complex aneurysms and dissections of the thoracic aorta, saying the technology could reduce the need for additional procedures and the associated risk of serious complications. Read More
Lawmakers in Japan have approved legislation paving the way for a distinct regulatory regime for medical devices. The measure raises industry hopes that long-awaited device regulations will soon follow. Read More
Disagreement among members of the Council of Europe over whether to allow reprocessing of single-use medical devices could hamper efforts to pass device reform legislation before next May’s EU elections. Read More
FDA user fees are protected from sequestration cuts for at least two years under Wednesday’s 64-36 Senate budget vote, which also recommends repeal of the medical device excise tax. Read More