New CDRH Initiative to Address Challenges of Home Use Devices

Noting a growing number of adverse event reports involving devices designed for home use, CDRH has launched a three-pronged initiative to address the unique safety challenges such devices face. The initiative will include new guidance, a public database and stronger accreditation criteria. From 1997 through 2009, the FDA received more than 19,000 reports of device adverse events that took place at home, according to an agency white paper released last week.
Devices & Diagnostics Letter