On July 29, 2011, the Institute of Medicine ("IOM") released its long-awaited report, “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.” Both industry and FDA were likely surprised by the IOM’s recommendation: do away with the 510(k) process as quickly as possible, and put in its place “an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
The IOM reached this decision based on a consideration of two questions posed to it by FDA:
- Does the current 510(k) clearance process optimally protect patients and promote innovation in support of public health?
- If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) clearance process?
The IOM stated that it was difficult to answer those questions, since it found that the 510(k) process was not intended to determine whether a new device provides a reasonable assurance of safety and effectiveness or whether it promotes innovation. Rather, according to the IOM, it was intended only to determine whether the new device is substantially equivalent to an already marketed (predicate) device, and there was therefore an inherent conflict between the legislative framework of the 510(k) program and the FDA’s stated goals.
On first glance, this might look good for industry. If FDA does not have the statutory authority to request information about safety and effectiveness (except to support the safety and effectiveness of technological changes), then the report could have concluded that FDA should just stick to its statutory mandate to determine whether a new medical device is substantially equivalent to a predicate. In fact, the first conclusion of the committee is that the 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” But, rather than simply telling FDA that it is going beyond its statutory mandate in trying to use the 510(k) process as a premarket evaluation of safety and effectiveness, and rather than proposing ways to “fix” the 510(k) process, the IOM stated that it “does not believe that further investment in the 510(k) process is a wise use of the FDA’s scarce resources and is not recommending specific changes in the 510(k) clearance process itself. Instead, it believes that the FDA’s resources would be put to better use in obtaining information needed to develop a new regulatory framework for Class II medical devices and addressing problems with other components of the medical device regulatory framework.”
The IOM did not, however, propose how FDA might use its “scarce resources” to obtain the information necessary to completely overhaul the entire medical device premarket approval program. The report repeatedly noted that the 510(k) clearance process is “not a stand-alone program, but a component of the larger medical device regulatory framework.” If FDA were to adopt the IOM’s recommendation to scrap the 510(k) program altogether (which is extremely unlikely), this raises the obvious question of whether changes would be made not only to the premarket pathway for Class II devices, but for Class and I and Class III as well.
Although it did not describe a specific regulatory framework, the report does provide what the IOM committee considers to be an “ideal regulatory framework”:
- The process should be based on sound science.
- The process should be clear, predictable, straightforward, and fair.
- The process should be self-sustaining and self-improving.
- The process should facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle.
- The process should apply relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness.
- The process should be risk-based.
These elements are broad and far-reaching, and not very controversial. However, they do not appear to provide FDA with any solid ground upon which to move forward with the IOM recommendation to conjure an entirely new pathway for medical device premarket review (which would, of course, need to be enacted by Congress). But perhaps that won’t matter, since FDA has already stated in response to the report that it “believes that the 510(k) process should not be eliminated,” but that it is “open to additional proposals and approaches for continued improvement of our device review programs.”
The committee also declined to comment specifically on whether the 510(k) process has an effect, for better or worse, on medical device innovation over the years. It concluded that “[i]nformation that would allow an understanding of the extent to which the 510(k) clearance process either facilitates or inhibits innovation does not exist.” It further noted: “The 510(k) process does not require a moderate-risk device to be innovative, nor does it reward innovation. However, the 510(k) process can facilitate innovation by making new devices available to consumers in a timely manner. It is unclear—and the committee concludes that it is indeterminable, given current information—whether the 510(k) process over the last 35 years has had a positive or negative effect on innovation. To answer this question, the FDA should commission an assessment to determine this effect.” Perhaps that is what FDA thought it was doing when it commissioned the IOM to address this issue, but apparently it was mistaken.
One subject on which the report does provide some detailed discussion is that of improving FDA’s postmarket surveillance system. The report states that FDA should give priority to postmarket surveillance as an “invaluable investment” in both short- and long-term oversight of medical device safety and assessment of device effectiveness. It also notes that although FDA stated that its postmarket authorities have “important limitations,” the committee did not seem convinced that such limitations exist, and the report encourages FDA to identify and address any such limitations.
One area that both industry and FDA are interested in improving is the de novo review process, an area on which the committee was to provide suggestions. Rather than specifically describing how the de novo process itself may be improved, however, the report states a “pilot program of a modified de novo process would allow the FDA to determine its feasibility as a replacement for the 510(k) clearance process.” The report does not indicate what that “modified” de novo process would look like, apart from expediting development of special controls, developing guidances, and adopting standards for devices.
So where does all this leave us? Though hard to say, there a couple conclusions that seem reasonable. First, the IOM committee specifically states that it “is not suggesting that all, many, or even any medical devices cleared through the 510(k) process and currently on the market are unsafe or ineffective. The continual use of many of these devices in clinical practice provides reason for a level of confidence in their safety and effectiveness.” Perhaps this will provide more confidence that most devices on the market are safe and effective for their intended uses, even if cleared through the 510(k) process. Second, FDA has already stated it does not think the 510(k) program needs to be completely scrapped and an entirely new medical device review program put in place. It wants to work within the framework that already exists. While IOM’s recommendation to get rid of the 510(k) process certainly gives FDA the ammunition to do just that if it wants to, the likelihood of that happening is low. Perhaps this means that industry need not worry about sweeping overhauls taking place any time soon, at least based on recommendations from the IOM.
FDA has already stated that it will be opening a public docket to receive comments on the report. Given the sheer breadth of the report, there may be many areas that will attract comments. So, for better or worse, perhaps the most reasonable conclusion is simply that nothing is bound to change for a good, long while, and it is no more clear today than prior to release of the report what those changes are likely to be.