According to an editorial published in the Minneapolis Star Tribune, Dr. Jeffrey Shuren, acting director of the CDRH, has confirmed that no sweeping changes are imminent for the 510(k) process. The rigor of the 510(k) pathway has been a subject of discussion for several years, with concerns punctuated by the clearance of ReGen Biologics’ Menaflex.
For the moment, the 510(k) process will remain as-is while the agency shifts management and awaits the results of several ongoing studies.
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“Editorial: Following scandal, FDA plots changes” Minneapolis Star Tribune… http://ow.ly/MiZV