Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
510(k) modifications guidance
You may also be interested in...
Regulatory News In Brief
FDA issues final guidances on 513(g) requests for information on device classifications. Panel to meet June 13 on expanded indication for Sapien transcatheter valve. More FDA news.
Call For Smarter Hospital Equipment And Alarms At AAMI Summit
Alarm-ready monitoring devices used in the hospital need to be smarter, which means comprehensive connectivity between devices and an improved ability to record and make sense of patient data over time, health care providers and FDA reps stressed at a conference last week.
FDA Outlines Next Steps In Regulatory Science
FDA plans to invest in eight priority areas for regulatory science, including better tools for reviewing innovative technologies and new manufacturing approaches, according to a strategic plan released Aug. 17.