FDA panel meetings in September:
This article was originally published in Clinica
Executive Summary
On September 20th the US FDA's anaesthesiology and respiratory therapy devices panel will consider a guidance document for premarket notification submissions for continuous positive airway pressure devices for treatment of obstructive sleep apnoea. The panel will also discuss the exemption of specific anaesthesiology and respiratory therapy devices from 510(k) review. At its meeting on September 25th, the neurological devices panel will vote on a PMA for an implantable upper extremity functional neuroprosthetic device.