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At the close of a comment period on the quality management systems reporting burden for devicemakers, the FDA received just one reply requesting a few clarifications. Read More
The FDA will soon begin identifying candidates for a pilot program that will let manufacturers self-identify and correct possible regulatory violations to avoid FDA inspection. Read More
Last year was a key year for advancements in device supply chain transparency, with the FDA’s September release of its final unique device identification rule. Read More
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
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