Home » Industry: TGA Premarket Scrutiny Plan Wouldn’t Catch Most Device Defects
Industry: TGA Premarket Scrutiny Plan Wouldn’t Catch Most Device Defects
Australia’s device industry is questioning the push for tighter premarket controls for high-risk devices following an analysis of the Therapeutic Goods Administration’s recalls database. Between July 2012 and May 2013, the majority of device-related recall actions involved lot-specific manufacturing issues or circumstantial faults such as hardware glitches, a leading trade group says.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor
Upcoming Events
-
25Apr
-
07May
-
14May
-
30May