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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.

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Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Deaths due to physical restraint. 2012 Jan;109(3):27-32. Dtsch Arztebl Int. PMC3272587.