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