FDA Hasn’t Implemented 2007 Measure to Reduce Low-Risk Reporting Burden

The FDA has failed to implement a 2007 mandate that would radically reduce reporting requirements for makers of low-risk medical devices. A clause in that year’s Food and Drug Administration Amendments Act calls for the FDA to eliminate 30-day reporting requirements for all Class I or Class II devices that are not permanently implantable, life-supporting or life-sustaining.
Devices & Diagnostics Letter