Today, the Center for Devices and Radiological Health (CDRH) released a 24-page report titled, "Improvements in Device Review" (available here). The report details how the agency believes their premarket approval (PMA) and 510(k) systems are performing after implementation of many of the initiatives in the 2011 "Plan of Action" to modernize and improve the agency's premarket review of medical devices (available here). The newly released report concludes that, while more work remains to be done, implemented reforms are working and device review performance has improved without compromising safety or effectiveness.
As an analytical foundation, the report generally compares Fiscal Year (FY) 2010 performance data with FY 2012 performance data. However, in some instances FY 2011 data was used where FY 2012 data was not yet available. FY 2010 data is used as a baseline because the agency began implementing certain reforms in FY 2010 and this period was the nadir of CDRH performance.
The report starts with a review of what the agency considers to be the reasons for declining performance in the 2001-2010 timeframe. The key reasons identified for the review problems include:
- Lack of financial and managerial resources
- Lack of predictability and consistency
- Problems with submission quality
- Reviewer turnover and training needs
- Increased work load
The report goes on to discuss the status of various agency initiatives and provide data on performance of the premarket review processes for 510(k) and PMA submissions. The initiatives discussed include final and pending guidances, new Standard Operating Procedures (SOPs) and key initiatives, such as the Entrepreneur in Residence program and the Center Science Counsel. The performance data, which compares FY 2010 to FY 2012 (or FY 2011 depending on data availability), is best summarized as follows:
- A 4-10 day decrease in time to decision between 2010 and 2012. However, the 2012 time for review is still slightly longer than 2009 and even longer if compared to 2001-2008.
- A decrease in pending 510(k)s (the 510(k) backlog). It should be noted that it is hard to separate how much of this decrease is attributable to process improvements and how much to fewer submissions.
- Increase in substantial equivalence determinations (i.e. clearances) as a percentage of submissions. The percentage of clearances went from 73% in 2010 to 80% in 2012, but this 80% number is still lower than the clearance rate in the 2001-2009 time periods.
- A 3% decline in 510(k)s receiving an "Additional Information ("AI") letter. In 2010, 77% of 510(k)s were issued an AI compared with 74% in 2012. The 2012 number is 2% higher than 2009.
- An apparent decline in total review time. Although, CDRH itself states the available data are not robust.
- A reported significant decline in the PMA backlog.
- A 2011 decline in the percentage of Major Deficiency Letters, with a possible uptick in 2012 based on early data.
- An 11% increase in positive PMA approval decisions from 2010 to 2012 (59% to 70%). In comparison, data from 2000-2008 shows approval rates ranging from 72% (2002) to 90% (2005).
It should be noted the report does not discuss performance data for supplemental PMAs or, of particular importance to small companies and venture capitalists, for IDE submissions. The report also does not address any impact of a decline in the number of actual submissions; however, CDRH does state that its workload has increased because of the complexity of submissions but not because of more submissions. One may assume that the general decline in new 510(k) and PMA submissions may be, at least in part, responsible for improvements in metrics such as submission backlogs.
Overall, "Improvements in Device Review" sets forth CDRH's case that its premarket review process improvement initiatives are starting to take effect across many areas. While this report readily acknowledges that additional work is needed and a number of initiatives remain to be completed, it is a useful summary (and reminder) of the plethora of efforts the agency is undertaking for the purpose of promoting an enhanced review process.