We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA will need to change its approach if it wants to regulate genomic medicine while encouraging the field to grow, a special report in the New England Journal of Medicine concludes. Read More
The number of adverse events reported by devicemakers in Australia jumped by more than a thousand in 2014, compared with the previous year, regulators say. Read More
Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, Chinese regulators say. Read More
Manufacturers of tanning bed ultraviolet and sunlamps that were offered for sale prior to Sept. 2, 2014, must submit 510(k)s to the FDA by Aug. 26. Read More
Foreign entities may now own up to 100 percent of an established Indian devicemaker without first getting government approval, under revisions to the country’s consolidated foreign direct investment policy. Read More
European lawmakers voted 402 to 118, with 171 abstentions, on Wednesday to require devicemakers that use tin, tantalum, tungsten or gold in their products to certify that the minerals aren’t sourced from certain conflict zones. Read More