Aug 18, 2015

A new report released by the US Food and Drug Administration shows a substantial reduction in instances where incomplete premarket applications are refused under the agency’s Refuse to Accept (RTA) policy, as well as decreases in overall review timeframes for medical device clearances and approvals between 2010 and 2014 fiscal years.

The agency reports reduced timeframes for 510(k) premarket notifications, premarket approvals or PMAs, investigational device exemptions (IDE) and de novo reviews of novel devices and technologies, citing various internal policy and program changes since 2010, as well as external factors related to the Medical Device User Fee Act (MDUFA) and the Food and Drug Administration Safety and Innovation Act (FDASIA).

Fewer RTA rejections in 2015
Another significant finding in the FDA report pertains to the agency’s Refuse to Accept (RTA) policy whereby 510(k) applications are initially screened for completeness and rejected if lacking required components.

The FDA reports a 20% decrease in such instances: RTA rates fell from 57% in the first quarter of 2014 to 37% in the second quarter of 2015. The FDA attributes this decrease to more training as well as greater RTA policy transparency for industry, which in turn may have led to fewer mistakes and omissions in 510(k) submissions to the regulator. Since the RTA policy’s introduction in early 2013, rates of rejection have steadily decreased, suggesting greater awareness on 510(k) applicants’ part of what must be included in a premarket notification submission to warrant substantive FDA review.

Substantial reductions for IDEs, de novo reviews
The most dramatic reductions were reported for IDE and de novo reviews; IDE review times fell by more than a year, according to the FDA, while de novo reviews decreased from more than three years in 2010 to 10 months in 2014. As Figure 1 shows, 510(k) and PMA review times also decreased by 13% and 31%, respectively.

Figure 1: Review Times in Number of Days for FYE 2010 and 2014 (source: US FDA)

Regarding the significantly shortened de novo review timeframes, that decrease may be explained by the FDA’s allowing manufacturers to submit de novo device applications directly without first having to go through a 510(k) review and obtaining Not Substantially Equivalent (NSE) decisions.

Shorter review times mean more clearances, approvals
The FDA report also demonstrated how decreases in review times have led to more medical devices cleared or approved for sale in the US market.

Specifically, the agency claims that the number of 510(k) applications cleared has grown to 84% in 2014 from 73% in 2010. PMAs approved by the FDA have also increased to 86% in 2014 from 59% in 2010.

Key Points

  • Substantial reductions in RTA rejections are due to FDA outreach as well as greater industry awareness of 510(k) submission requirements
  • A more direct de novo application process has cut down market authorization timeframes for these types of medical devices
  • Program and policy changes at the FDA’s Center for Devices and Radiological Health (CDRH) have led to decreased review times for 510(k) and PMA applications



  • Stewart Eisenhart