The FDA’s Center for Devices & Radiological Health last week reported significant progress in speeding up the U.S. regulatory approval process for medical devices.
The FDA said it exceeded its 2014 goals for streamlining the process, as part of a larger initiative to bring needed devices to market more quickly without sacrificing patient safety, according to the safety watchdog’s Jan. 23 update.
The number of investigational device exemption applications requiring more than 2 review cycles fell 34% from 2013, according to the report. The agency had targeted a reduction rate of 25%. Likewise, the median time for full IDE approval was reduced by 53% in 2014, surpassing the agency’s goal for a 25% reduction.
“We’re excited to report that these changes have greatly shortened the time for an IDE to reach approval, so that a clinical trial can begin. From 2011 to 2014, the median number of days to full IDE approval has decreased from 442 to only 101. This cuts the time it takes to bring a new medical device to market by nearly a full year,” CDRH officials wrote in a post on the "FDA Voice” blog.
The FDA also was able to shorten the amount of time it took to meet with sponsors to discuss a failed IDE application. The agency said that during the last 5 months of fiscal 2014, it was able to offer at least a teleconference meeting with sponsors within 10 business days of the rejection.
For fiscal 2015, the agency said it plans to issue draft guidance on benefit-risk determinations for IDEs and adaptive clinical studies. The FDA has also developed a real-time metrics system to track CDRH, IDE and clinical trial performance.
Regulators have also been reviewing the pre-market applications for devices already on the market to see what types of data could be shifted from the pre-approval to post-approval stage without sacrificing patient safety or product effectiveness. The FDA is also evaluating whether some device applications should be re-classified to speed approval. As of the end of fiscal 2014, the agency had reviewed 69% of the device types subject to PMAs. The bureau said it plans to publicly announce those findings by April 15.
Also on deck in 2015: Final guidance for a new, proposed approval pathway for high-risk devices targeting life-threatening or severely debilitating conditions for which there are few medical options.
