QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year's End

All signs point to the US agency exercising enforcement discretion for device-makers when it rolls out a new final rule that merges the Quality System Regulation with international standard ISO 13485. "We'll give companies time on the transition," FDA device center chief Jeff Shuren said at the MedTech Conference on 25 September. Meanwhile, an industry insider tells Medtech Insight that a draft of the regulation probably won't be out until the end of the year because of "disagreements technically on the inside" of the agency.