Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA delivers first report on foreign offices to Congress. Agency denies citizen petition on IOM 510(k) panel. More regulatory briefs.
You may also be interested in...
Special-Controls Guidelines Address Tryptase Tests To Aid Mastocytosis Diagnosis
Following on its 2012 de novo reclassification of tryptase assays to help diagnose systemic mastocytosis, FDA issued special-control guidelines Sept. 18.
FDA To Survey Clinicians About Adding “Highlights” Section To Device Labeling
FDA wants to know what information physicians, nurses and technicians would like to see in a shortened "quick guide" version of labeling as part of an effort that could result in more standardized device labeling.
Regulatory News In Brief
Radiological health post-market offices moving to OIVD. FDA issues global engagement report. More regulatory news.