New FDA Pilot Program To Finger ‘Critical-To-Quality’ Points; First Up: Implantables With Batteries
This article was originally published in The Silver Sheet
A “critical-to-quality” pilot program will launch early next year to help hone FDA investigators’ attention on manufacturing processes that are essential to the quality of implantable devices that include batteries. The agency, along with manufacturers and other stakeholders, will develop so-called “CTQs” that investigators will use to supplement FDA’s traditional QSIT inspectional approach. If the pilot goes well, FDA will likely develop a similar CTQ model for inspections of manufacturers that make devices other than implantables with batteries. Next for potential CTQS: cardiovascular products, IVDs, and general hospital and surgical devices?