Regulatory News In Brief
This article was originally published in The Gray Sheet
Diagnostics office launches “Triage" pilot, aimed at providing 30-day reviews for good quality 510(k) submissions. UDI database to be tested. More regulatory news.
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The first month of the diagnostics office’s “triage” pilot program has led to quicker reviews for some 510(k)s, an agency official reports. To qualify for the program's quick-review pathway, a submission must be of high quality and free of certain time-consuming complexities.
The Senate Appropriations Committee approves a $3.9 billion budget for the agency in fiscal 2013, including $319 million in federal funding for device activities.