The FDA released a report detailing improvements in clearing medical devices, stating it reduced investigational device exemption times by roughly a year.
In the report, published as part of the agency’s renewal of the Medical Device User Fee act, the federal watchdog covered the agency’s improvements over the past 5 years at hastening its time-to-decision for IDEs, pre-market approvals and 510(k) clearances.
The improvement in IDE clearances was the most distinct, with the FDA saying it reduced the time-to-decision for investigational devices from an average of 442 days in 2011 to only 30 days in 2015. The agency said the percent of IDEs approved within 2 cycles increased from 15% in 2011 to 72% in 2015.
The agency reported distinct reductions in PMA times, from an average time to decision of 352 days in 2009 to 242 days in 2014, clocking a 31% reduction. The agency added that it projected performance for 2014, once all applications are closed, would be on par with 2014.
The agency said it is closing the gap between the fastest and slowest times to PMA approval, reducing the maximum difference from 633 days in 2008 to 197 days in 2014.
For 510(k) clearances the reduction was smaller, clocking a 13% faster processing time from the average of 132 days in 2010 to 115 days in 2014. The FDA said it improved the gap between the slowest and fastest 510(k) review times at its different review branches, with its slowest branch reaching decision in 90 days only 34% of the time in 2003, compared to 81% in 2014.
“These improvements include those to 510(k) and premarket approval review times along with a reduction in Investigational Device Exemption review times of almost a full year-which means many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade,” the agency wrote in the report.
The FDA said the improvements were partially due to its Safety and Innovation act as well as increased User Fee Act, but neither act distinctly changed the FDA’s framework for device oversight.
“Enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) and increased Medical Device User Fee Act (MDUFA) funding facilitated some of the performance improvements in the device program. But neither FDASIA nor MDUFA altered the fundamental components of FDA’s flexible, risk-based framework for device oversight,” the agency wrote.
The federal watchdog also detailed program improvements and policy changes it made over the past 5 years.
Included in the improvements were the implementation of a clinical trials program to improve the agency’s ability to review clinical investigations of devices, recalibrating the benefit-risk framework in premarket reviews.
The agency said it also cofounded a public-private partnership to promote the development of regulatory science tools and adapted premarket and post-market oversight to keep pace with new tech.
“Importantly, these advances in the performance of the device program reflect a combination of programmatic improvements and innovative approaches to applying existing authorities, rather than changes to the basic framework for device oversight that was put in place almost 40 years ago. The existing framework assures that FDA’s level of oversight matches the level of device risk, and applies flexible standards to premarket review of devices without compromising the standard for safety and effectiveness of devices,” the FDA wrote.