The device center’s priorities for guidance development shift throughout the year based on evolving urgencies and mandates, and are not fully reflected on the public website. CDRH described its process at a meeting this month, and heard guidance wish lists for industry and other stakeholders.
CDRH annually prioritizes about one-third of the guidance documents it hopes to get out quickly and continuously analyzes its own progress. Nonetheless, limited resources and congressional input means that not all prioritized documents will be issued before the fiscal year ends, a device center policy official says.
Phil Desjardin, associate director for policy at CDRH, discussed the center’s priority-setting process and, with other FDA managers, took feedback...
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.
