New York State’s medical technology industry is home to multinationals such as Welch Allyn and Bristol-Myers Squibb, and to startup companies whose innovative ideas could be the next big thing. For medical device manufacturers of all sizes, the U.S. Food and Drug Administration’s (FDA) recent announcement about expediting the regulatory process is welcome news.
According to a recent article in Mass Device, the FDA’s Center for Devices and Radiological Health (CDRH) reported exceeding its 2014 goal for bringing medical devices to market faster – and without compromising patient safety. According to CDRH, the number of investigational device exemption (IDE) applications requiring more than 2 review cycles fell 34% from 2013. The agency had targeted a reduction rate of 25%.
The agency’s achievement is the latest development in a multi-year trend. From 2011 to 2014, the median number of days to full IDE approval fell from 442 to 101. As CDRH officials explained, “this cuts the time it takes to bring a new medical device to market by nearly a full year.” For sponsors of rejected applications, CDRH was able to offer a teleconference within 10 business days of the rejection.
For fiscal 2015, CDRH plans to issue draft guidance on benefit-risk determinations for IDEs and adaptive clinical studies. Meanwhile, the FDA has developed a real-time metrics system for tracking IDE and clinical trial performance, and plans to offer final guidance for a proposed approval pathway for high-risk devices that target life-threatening or seriously debilitating conditions for which there are few medical options.
Are you a New York State manufacturer of medical devices? Are you encouraged by news of FDA’s recent achievements, and do you expect an even faster regulatory process in 2015?
