There’s been a lot of talk lately about how the FDA clearance process is doing, and whether it is working or not, depending on who you talk to.
Emergo Group did a study in which they found that application times jumped 37% from 2006 to 2010. In 2006 510(k) applications cleared by the FDA took about 96 days, but that number soared to 132 days in 2010.
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.
Technology is rapidly changing – and diverging further from current technology, thus making SE (Substantially Equivalent)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.
Sen. Al Franken (D-Minn.) sent a letter to Dr. Jeffrey Shuren, director at the Center for Devices & Radiological Health at the U.S. Food & Drug Administration, that urged the agency to include industry input on any recommendations the Institute of Medicine makes about changes to the 510(k) process.
CDRH director Jeffrey Shuren said seven new guidelines are now in preparation, covering the following subjects:
- Device modifications that will trigger a 510(k) (expected in June).
- Preparing 510(k) submissions (this will include a flow chart indicating what constitutes a new intended use and when clinical data are needed).
- Emerging technologies (with device-specific guidance).
- How to conduct clinical studies, including the application of least burdensome principles (due in July).
- Conducting first-in-human studies.
- Conditional approvals (due in late October).
- Factors in making benefit and risk determinations (including a discussion of such issues as disease severity and relation to patients’ tolerance of risk).
I, for one, will be interested to see where the whole process leads us.