It’s tough enough getting a 510(k) through a smooth and timely FDA review. But many manufacturers discover to their cost a trap for the unwary right inside the FDA front door. FDA has since the early 1990s screened 510k submissions for completeness. This policy was tightened in 2012 – requiring that applications pass a detailed screen before acceptance for review. With rejection rates at times almost 60% it’s essential that anyone contemplating a 510(k) submission follows the requirements – to the letter.
Archives for September 2015
Leading experts from ISO, along with Senior regulators will meet in Guangzhou in September to discuss evolving approaches to biocompatibility evaluation. In a special workshop at the China International Medical Device Regulatory Forum, the experts will discuss the planned changes in ISO 10993 norms, including greater reliance on chemical characterisation, reduction in animal models and a strengthened risk management framework.