www.fdanews.com/articles/157095-new-devices-don-t-need-special-warning-industry-tells-tga
New Devices Don’t Need Special Warning, Industry Tells TGA
July 16, 2013
Australian devicemakers have come out in opposition to a government proposal that new devices have special labeling. The proposal, known as “new-to-market risk communication,” would add a symbol to labeling for all new therapeutic products so that users could take time on the market into consideration in making healthcare decisions.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor