2009 has arrived and with it a MyRAQA year-in-review of IVD regulatory highlights!
- OIVD cleared 285 products in 2008!
- The ASR guidance document was finalized and many companies received reminder letters from the FDA.
- Two more IVDMIA clearances - Pathwork and XDx
- LabCorp takes OvaSure off the market after regulatory questions are raised by FDA.
- CDC and AB got a new flu panel cleared.
- The differential flu guidance got published.
- Steve Gutman retires from OIVD - we'll miss you Steve!
- Rumors continue to swirl about the fate of the draft IVDMIA guidance... but nothing official yet.
- Genetech files a citizen's petition asking that all LDTs be FDA regulated.
