In Case You Missed It: Top 10 "Gray Sheet" Stories In August
This article was originally published in The Gray Sheet
Our feature exploring the myriad complications of the ongoing revision process for the international device quality systems standard ISO 13485 attracted the most "Gray Sheet" Web traffic by a long shot last month. Also popular: stories on a gap in warning letter postings; a Google device spinoff; China device reforms; and more.
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FDA takes new enforcement actions against duodenoscope makers in Aug. 12 warning letters to Fujifilm Medical Systems, Hoya and Olympus Medical Systems, charging adulterations to scopes, and noting troubles with CAPAs and reprocessing validation activities. Meanwhile, Fujifilm and Hoya also received so-called "510(k) status" letters.
Amarin Corp. PLC's First Amendment legal victory on Vascepa (icosapent ethyl) may intensify pressure on FDA to develop new guidance and regulations governing off-label promotion before its hand is further forced by more adverse court rulings and Congress.
The agency has so far approved a total of 36 original PMAs and panel-track supplements in 2015, the highest total at this point in the year since 2001.