On March 14, 2017 the US FDA published a notice in the Federal Register (FR Doc Number 217-04938) indicating that the Agency has identified a list of Class II devices that, when finalized, will be exempted from premarket notification requirements (i.e. 510(k)). The list encompasses 1,003 class II devices, many of which were previously identified […]
On March 2, 2017 the US FDA and the European Medicines Agency announced that the Agencies had completed an exchange of letters amending the 1998 US-EU Mutual Recognition Agreement. The exchange of letters is the culmination of nearly three years of work between the two Agencies that began in May 2014 with the initiation of […]
Since returning from the country’s New Year Celebration in early February, the China FDA (CFDA) has released a minimum of six new technical review guidelines. These new guidelines include: Device: Bone Filling Materials Class III, Release Date: February 10, 2017 This technical review guideline addresses bone filling materials (i.e. silicone/calcium phosphorous) are utilized to repair […]
