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Report: FDA should scrap 510(k) process

7/29/2011 02:56 PM EDT
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Steven Dean
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re: Report: FDA should scrap 510(k) process
Steven Dean   8/11/2011 5:00:39 PM
Hi Rick. I’m glad you’re writing about this as it’s a hot topic not only for Medical OEMs, but also for their suppliers, which is where I live. The uncertainty and subjectivity of the current model does impact product development strategy and most certainly time to market. My take on the subject of federal review; *So long as the resultant changes come soon. *So long as the resultant equivalent of the 510K process today provides positive patient outcomes, patient safety, while at the same time provides a predictable platform for the Medical OEM submission and review process. *I’ll inject the idea of streamlining the approval process for companies whose baseline and track record in the field are exemplary; more regimented for those companies with known quality issues. *AND… Medical OEMs routinely launch in the EU first as the CE process is always mentioned as much more objective, structured and more predictable. What about a model that more closely aligns with the CE process in Europe? It seems to work well. Hope to see you at ESC/DesignMed Boston - Best Regards, Steven Dean Global Healthcare Segment Lead Freescale Semiconductor

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