Shawn M. Schmitt
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Latest From Shawn M. Schmitt
Reimagining The 'Case For Quality': FDA Looking At More Hands-Off Approach, CDRH Director Shuren Says
In an effort to step back some from its role as a ringleader for the Case for Quality initiative, US FDA wants to create a "collaborative community" so various industry stakeholders can have a say in the six-year-old scheme that aims to drive a quality mindset throughout device manufacturing organizations.
US FDA addressed quality systems and recall violations at the Florida maker of ProSun SunDream tanning beds in the only device-related warning letter posted this week.
Medical device manufacturers might be tempted to defend themselves during a US FDA inspection. But longtime industry insider Steve Niedelman says there are 20 instances in which firms should remain tight-lipped.
Almost six months into its new "program alignment" inspection approach, FDA's initiative to inspect along commodity lines is still gaining its sea legs. A key FDA official says the agency is taking steps to train and retain specialized investigators. Meanwhile, FDA wants to use a geographic information system (GIS) tool to keep tabs on where investigators are inspecting.
While overall medical device recall events fell 39% in the third quarter of 2017, recalled units ticked up slightly due to sterility problems. Check out our Q3 recalls infographic.
The global regulatory environment for devices and diagnostics is rapidly evolving, with new frameworks, rules and directives rolling out around the world. To help keep up during this period of fundamental change, Medtech Insight has launched a new interactive timeline.