FDA has a 90 day statutory review time for 510(k) submissions. At the end of the 90 days, FDA must issue a decision letter – a Clearance letter, through which FDA allows you to market your device; a Non-Substantially Equivalent (NSE) letter, with which FDA determines that your device must follow a different submission path (PMA or De Novo); or a Deficiency letter, by which FDA requests you to provide them additional information for review of the device. Recently, FDA has been criticized for their long, drawn-out reviews of 510(k) submissions. In a recently published report, Emergo Group Research presents an analysis of average 510(k) review times, in which it reports that FDA review times have increased 37% since 2006. The group reviewed 13,621 submissions cleared between 2006 and 2010 and found that the average review time in 2006 was 96 days, but had increased to 132 days in 2010. This report is in line with FDA’s March 7, 2011 presentation where they reported that the average review times were 93 days in 2006 and 148 days in 2010.
Since we keep a log of the 510(k) submissions that we support here at Anson – and we track clearance times, I decided to compare the data for Anson-supported submissions with Emergo Group’s data. Keeping in mind that the Anson sample size is much smaller than that used in Emergo Group’s analysis, I nonetheless find that Anson submissions come in with similar review times. The average review time for submissions supported by Anson was 94 days in 2006 and 105 days in 2010. So, while we have seen longer review times – especially for some particular submissions, our average has gone up only slightly overall.
So, what else did Emergo Group find through their analysis? Even though the review time average has increased, more than half the 510(k) submissions were cleared within the statutory 90-day window – and 80% of the 510(k) submissions were cleared within 6 months! Furthermore, of all of the medical devices submitted to FDA, more than half fall into one of these categories: orthopedic, cardiovascular, general/plastic surgery, and radiology. This is great news for a considerable portion of industry and 510(k) submitters. In fact, at 72 days, radiology devices have the lowest average review time of all of the device categories. Anson supported submissions within these four categories averaged an 88 day clearance time.
But, why are the reviews at FDA taking longer? As part of the MDUFMA/FDAAA reauthorization in 2007, FDA made a promise for interactive review process in a commitment letter to Congress. The Agency stated that it “will continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and sponsors to facilitate timely completion of the review process based on accurate and complete information.” The purpose of the interactive review process is to prevent unnecessary delays in the completion of the review, to avoid surprises to the sponsor at the end of the review, and to minimize the number of review cycles. This process would benefit both FDA and 510(k) sponsors, but are reviewers using this process? According to a presentation made by FDA in March 2011, FDA reviewers utilized the interactive review process less in 2010 than they had in previous years. Upon surveying their staff, FDA discovered that the reviewers have chosen not to use the interactive review process because:
- Additional test data is required (which will take a long time to acquire)
- The review is going to result in a major deficiency/AI letter
- Not enough time was left on the review clock
- Verbal communication with the sponsor is not effective (foreign sponsor)
Ok, so there are instances in which the interactive review process may not work or make sense. The most common reasons reviewers cite is that additional testing is needed or that other major deficiencies have to be addressed. Interestingly, this correlates with FDA’s report on Initial Results of 510(k) Audit: Analysis of Not Substantially Equivalent (NSE) Determinations (June 15, 2011), in which they reported that the top reasons for an NSE determination are:
- Unsuitable Predicate device
- Intended use doesn’t match the predicate
- The technology is substantially different from the predicate
- Performance data was not provided or found to be inadequate
Technology is rapidly changing – and diverging further from current technology, thus making SE decisions harder to prove and review. As new technology becomes more ever more divergent from the predicate device, it becomes all the more difficult for the FDA reviewer to agree with the sponsor’s proposed SE strategy, resulting in longer review times. Quite often the 510(k) submitters aren’t providing FDA with adequate scientific data (performance data) and/or SE strategies (appropriate predicate devices). The bottom line result of these trends is longer review times.
There is clearly room for improvement from both FDA and the 510(k) submitters. While FDA is working on changes to their system and practices, it is clear that 510(k) submitters will have to do the same. If the 510(k) submitters do not change and/or improve their practices, changes may be imposed by FDA – and industry might not like the end result.