Shawn M. Schmitt
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Latest From Shawn M. Schmitt
Device-makers that are shut out of the US agency's Case for Quality Voluntary Improvement Program (CFQ VIP) because of poor compliance histories may soon be able to join an alternative initiative that would use an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework to assess manufacturing maturity and quality.
In the only device-related warning letter released by the US FDA this week, the maker of Bounder wheelchairs was cited for premarket and Medical Device Reporting violations.
In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc.
Q2 Recalls Snapshot: It's A Mixed Bag For Industry As Recall Events Jump Slightly And Recalled Units Fall Dramatically
There were 200 recalls initiated by device-makers in the second quarter of 2019, a 22% increase over Q1, when 164 were reported. Conversely, the number of recalled device units fell from 135 million in Q1 to 19.7 million in Q2 – a decrease of 85%. Check out our Q2 recalls infographic.
FDA's Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI
A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation compares regulatory requirements found in the US FDA's QSR to those in quality systems standard ISO 13485:2016. While the 146-page document is aimed at US device-makers, it could also be helpful to the FDA as the agency works to harmonize its QSR with the ISO standard.
Concerns about paclitaxel-coated balloons and stents, as well as recalls linked to two large device manufacturers, captured the attention of many of our online readers last month, as did compliance-focused features that offered tips and advice from US FDA officials. Here are August's 10 most popular US regulation and policy stories from Medtech Insight.