Stephanie Fox-Rawlings, PhD, National Center for Health Research, May 31, 2019
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our Center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.
We understand the desire to make it easier for new products to get on the market, but down-classifying collagen-based hemostatic devices would allow similar products to enter the market with much less scrutiny.
The collagen-based hemostatic devices currently on the market have been shown to have benefits that outweigh the risks. To ensure that any new versions of these products are as safe and as effective as those already on the market, new products should be tested in clinical trials. Different formations of collagen-based devices or different sources of collagen may have not have the same level of benefit or the same risk profile as currently approved devices. Changes in the delivery system can also affect these profiles. “In vivo examination” in a small number of animals or humans may not accurately identify these differences. Well-designed clinical trials with appropriate controls and a sufficient number of participants are needed to determine if the benefits of a new product outweigh its risks.
A major problem with the 510(k) pathway – which is used for Class II devices — is that it does not establish either safety or effectiveness of new devices. This was the conclusion of an Institute of Medicine report back in 2011 and is still a problem today.
Most Class II devices are not reviewed by this Advisory Committee, so I will quickly summarize the problem: Instead of demonstrating that a device is safe and effective in clinical trials, Class II devices must have evidence that they are “substantially equivalent” to a device already on the market. That might seem reasonable, but the definition of substantial equivalence has been widely criticized in the medical literature and the media. FDA has allowed Class II devices to be sold even when they vary dramatically from previous devices, such as using different materials and having a different mechanism of action. Special controls are supposed to support claims of safety and effectiveness, but without clinical trials they are frequently not sufficient.
Even more concerning, devices that have been recalled or removed from the market because they do not work or have unacceptable risks can still serve as a substantially equivalent device for a new Class II device.
This means that while current collagen-based hemostatic devices may be safe and effective, this may not be the case for future “substantially equivalent” devices, which could put patients at undue risk for harm.
Changing the classification of these devices could benefit some companies that want to sell these devices, but it may harm patients or their physicians. Patients and physicians can’t make informed treatment decisions without clear scientific evidence of safety and effectiveness.
There is currently no system in place that includes all or even most adverse events that occur due to collagen-based hemostatic devices or most other devices. The current reporting system relies on voluntary reporting by patients or health professionals and comprise only a small proportion of the adverse events that occur.
The FDA does not have the authority to require post-market studies of new Class II devices unless evidence arises later that they might be less safe or less effective than expected. This would typically be delayed for years after the product is sold. Meanwhile, thousands of patients can be harmed.
The safety and effectiveness of new devices needs to be established before they are approved. Approval of products without this evidence puts patients at risk for unnecessary harm. Adequate and well-controlled clinical trials are the best way to establish that the benefits outweigh the risks for patients needing collagen-based hemostatic devices.
The General and Plastic Surgery Devices Advisory Committee concluded that collagen-based hemostatic devices should be reclassified from Class III (high risk; subject to Premarket Approval) to Class II (moderate risk; subject to General and Special Controls).