On November 28, 2012, CDRH issued a report titled “Improvements in Device Review,” addressing progress in the Center since issuance of its “Plan of Action” in January 2011. The report states that since the Plan of Action, “the speed and predictability of device review have improved for the first time in almost a decade, including significant reductions in the time it takes FDA to review applications and the size of application backlogs.”
A brief review of the Plan of Action and reasons for its implementation may be helpful in understanding the genesis of this recently released report. In response to concerns raised by industry, consumer groups, and CDRH employees, CDRH began an evaluation of its premarket review process in late 2009. In August 2010, in response to internal reviews and public feedback, CDRH released two reports. The first identified problems with its premarket review process, and the second addressed CDRH’s use of science in regulatory decision-making. The main problem identified in the premarket review process was unpredictability, “including uncertainty about the requirements for approval and the likely length of the review process, as well as inconsistencies and mid-stream changes in what information was required to obtain approval.” CDRH issued its Plan of Action in January 2011 to address those concerns. It included 36 action items, many focused on the major causes of unpredictability.
The November 2012 report assesses progress on those items, including:
- More efficient review of lower risk products;
- Increasing reliance on national and international device studies and standards;
- Enhancing reviewer training;
- Providing better, timelier guidance to CDRH staff and industry on requirements for clearance and approval;
- Reducing unnecessary and inconsistent data requests;
- Promoting greater transparency, interaction, and collaboration between FDA and industry during premarket reviews; and
- Improving CDRH’s understanding of new device technologies.
The report also discusses CDRH’s action to support innovation, including the Innovation Pathway, the Entrepreneurs-in-Residence program, and creating incentives for conducting clinical trials in the U.S.
According to the report, some of the specific positive trends resulting from the Plan of Action include:
- The average time it takes to clear a 510(k) began declining in 2011, for the first time since 2005;
- The backlog of 510(k)s pending for more than 90 FDA-days dropped by almost two-thirds from its high in 2010, dropping for the first time since 2005;
- The percentage of 510(k)s for which CDRH requested additional information during the first review cycle has decreased;
- The average time to reach a decision on a PMA has been reduced by approximately one-third since 2010; and
- The percentage of 510(k)s cleared and PMAs approved has increased since 2010. FDA attributes this to “improvements in the quality of applications and the consistency of review standards.”
While these initial numbers are encouraging, it is understandable if industry remains cautious. It is a bit too soon to consider these results to be “trends.” Though some of CDRH’s action items actually went into effect in 2010, before issuance of the Plan of Action, the results described in the report are based on, at most, one and a half years of data: all of FY2011, and limited information from FY2012. It will be interesting to see what the data look like in another year.
Industry can, however, take comfort in the number of efforts underway at CDRH to improve the review process. There is no question that CDRH has issued a large number of draft and final guidance documents in the last two years, many of which should prove very useful to both industry and CDRH in improving the premarket review process. Additionally, improvements in reviewer training and the increase in informal interactions are positive steps.
Hopefully, CDRH will not take the initial results as a necessary sign of success, but will instead continue to work towards improving its premarket review process and relationship with industry.