The Food and Drug Administration (FDA) issued preliminary recommendations for changes relating to the 510(k) program under which many medical devices are approved. The three key proposed changes include:
– A streamlined pathway for lower-risk denovo devices;
– A new subclass (Class IIb) for moderate-risk devices; and
– The creation of an internal CDRH Science Council
According to Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), one of the reasons that FDA wants to streamline the pathway for lower-risk de novo devices is because the current (de novo) process is “broken,” lengthy, and can take many years.
With respect to creating a new subclass (Class IIb) for moderate-risk devices, Dr. Shuren noted that CDRH would issue a new guidance document clarifying what companies need to submit for these devices, which are those for which clinical or manufacturing information would typically be necessary to prove substantial equivalence.
Dr. Shuren said that typically only 8%-10% of Class II devices need clinical data, and the type of data needed is wide ranging — sometimes a few patients, sometimes just to answer a question, not the kind of studies we envision for PMAs (premarket approval applications). Consequently, he recognized that since there tends to be a lack of predictability in these cases about which devices might need clinical or manufacturing data, CDRH intends to identify upfront for industry and split this off to Class IIb, so that industry will know if there is a high expectation of needing clinical data. He further added that by creating class IIb is a way of capturing what CDRH would otherwise be doing, but to do so in a transparent way.
Highlighting this change, Dr. Shuren gave the example of CDRH’s experience with infusion pumps, which he said would be something in Class IIb. He explained that by telling industry to conduct a ‘usability’ study and informing them through guidance documents, it gets to problems of device design failure. He predicted that in the future, CDRH will do this more quickly in Class IIb.
The third key recommendation creates an internal Center Science Council, which would be comprised of experienced managers and employees, under the newly-created position of Deputy Center Director for Science. Already chosen for that position, is Dr. William Maisel, an electrophysiologist who is known for his investigation of implantable cardiac defibrillation (ICD) lead failures. In addition to being responsible for overseeing science-based decision making, periodically auditing decisions, and assessing program performance, Dr. Maisel will also serve as the CDRH Chief Scientist.
It was noted that two examples of technology that are likely to be overseen by the Center Science Council are antimicrobial-coated products and device software.
Another proposal from FDA is to use a social network to develop a web-based network of informal outside experts, and to also enhance training and professional development for in-house staff. Dr. Shuren acknowledged that individuals chosen for this network may have a relationship with manufacturers, but that will be offset by other experts in the field without ties to industry. Either way, individuals will be vetted by the FDA in advance.
Next, FDA proposes to create a standardized “Notice to Industry” letter, generally issued as a Level 1 – Immediately in Effect guidance document, to quickly communicate when CDRH has changed its premarket regulatory expectations due to new scientific information about a certain type of device. Dr. Shuren said that these notices are needed to help strike a better balance and predictably, which is adapted to new science. He hopes that such notices “can get out the door within a matter of weeks,” even though they will also be put out for public comment.”
FDA also proposed revising regulations to explicitly require companies to provide a summary of all scientific information known or that reasonably should be known regarding the safety and effectiveness of the device being submitted—which currently is not a requirement. Dr. Shuren emphasized this proposal because that information is incredibly important to help CDRH be better informed upfront so that they don’t have to ask many follow-up questions, which results in delays. He added further that “getting information that the manufacturer already has or should have, like articles published in the public literature, would help streamline the process, and would not be much of a burden on industry.”
Moving along, FDA wants to also consider clarifying how and when CDRH would remove an unsafe device from the market and preclude its use as a predicate device, something which CDRH may need additional authority for. Specifically, CDRH would like to issue regulations on rescissions, so it is clear to everyone involved under what circumstance CDRH might pursue a rescission, what procedures they might follow, and what timelines. Dr. Shuren noted that 100 rescissions over the history of the Program have occurred for various reasons, most of which were related to fraud type of situations.
Similar to this issue, FDA also proposed issuing new guidance on when a device should not be used as a predicate (e.g., when a device was recalled for safety reasons), especially since 29% of 510(k)s submitted in 2009 cited a predicate no longer on the market.
Another proposal by FDA is for greater use of public databases, updating the CDRH website, and creating a searchable online public database. Dr. Shuren believed this proposal is important because it can be very helpful for industry to see labeling, summaries of CDRH 510(k) decisions, photographs and schematics of devices. Presently, it is difficult for manufacturers to get this kind of information regarding predicates because it is limited on the CDRH website. He stated that presently the agency is working to put out FDA-developed summaries for all 510(k) clearances for industry to see why they made the decision so that people can see their decision-making process.
In addition to his information, CDRH wants manufacturers to provide them with the final label they use for devices at the time of clearance or shortly thereafter so that they can provide one-stop shopping for the public on labeling. FDA also noted that their proposals were not meant to try and stop off-label use of devices, but rather the agency wants the approval to be for the indication the manufacturer intends to be the primary use.
Last but not least, FDA wants to go back into its original guidance and clarify some of the terminology it uses since the agency’s own staff and industry have differences of understanding key terms.
Given these proposals, the public now has the opportunity to comment for 60 days. After reviewing the public comments, the FDA will announce which improvements it plans to implement and the timeline for that implementation.
At the same time, the Institute of Medicine (IOM) will also carry out a parallel, complementary assessment of the 501k changes, which is due to be released in summer 2011. While CDRH focused their review on actions they could take under existing authorities, IOM will also be considering whether there are legislative changes that are needed. Dr. Shuren noted that if there is strong support for any recommendation, CDRH would be in a position to make those changes now. For anything controversial, they would refer it to IOM for them to consider in their deliberations.
In the end, although Dr. Shuren said he doesn’t see the new proposals leading to fewer devices going through 510(k), there is no evidence to support his claim. While CDRH uses science to guide its regulation of medical devices, and said the proposed changes merely show a smarter FDA, it is crucial that CDRH actually find a way to balance the sometimes conflicting goals of protecting the public and encouraging device development.
With our healthcare system facing an influx of patients, a shortage of providers, and a growing demand for new technology and devices to treat, prevent and detect diseases of all kinds, patients and physicians cannot afford to lose valuable devices because of a slow regulatory process.
Accordingly, comments sent to FDA should be clear in recognizing that the role of industry collaboration with physicians, academia and government must remain strong and transparent so that companies can continue making advances that will both encourage device development and protect the public health.