Embedded Systems Conference
Breaking News
News & Analysis

Report: FDA should scrap 510(k) process

7/29/2011 02:56 PM EDT
More Related Links
View Comments: Newest First | Oldest First | Threaded View
Steven Dean
User Rank
re: Report: FDA should scrap 510(k) process
Steven Dean   8/11/2011 5:00:39 PM
Hi Rick. Iím glad youíre writing about this as itís 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. *Iíll 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. *ANDÖ 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

Most Recent Comments
Navigate to Related Links
Flash Poll
Like Us on Facebook

Datasheets.com Parts Search

185 million searchable parts
(please enter a part number or hit search to begin)
EE Times on Twitter
EE Times Twitter Feed
Top Comments of the Week