An FDA investigator observed two different products with the same lot number at a manufacturer of cannulas and trocars; employees at Lusys Labs – a maker of in vitro diagnostic kits – handled and packaged coated membranes with bare hands; procedures at software-maker Merge Healthcare allowed for devices that hadn't fully completed design validation to be shipped to end users for clinical use on patients; and more. Six device warning letters were listed by FDA this week.
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The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.
The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.
The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.
