FDA To Roll Out New Medical Device Approval Process
Dangerous Medical Devices Could Be Available Sooner To The Public
December 15, 2017
The U.S. Food and Drug Administration plans to roll out a new approval process in 2018 to make new medical devices available sooner. The attorneys at TheLawFirm.com are concerned that this will be dangerous to patients. The new FDA plan will allow some devices to enter the market even as the manufacturers and the FDA gather evidence on their safety and performance. The new process would rely more heavily on information obtained on from how a device performs in the real world after it is cleared for sale rather than in clinical trials before it is approved. The FDA commissioner calls this new approval process ‘more progressive’.
However, TheLawFirm.com is concerned that the bar will be furthered lowered when it comes to determining that medical devices are safe and effective. While Big Pharma is undoubtedly in favor of this plan, attorneys and consumer groups have been warning that, even under the current process, defective devices regularly slip through the regulatory process.
Pelvic mesh is a perfect example. Researchers at Oxford University found 61 brands of pelvic mesh made it onto the market largely through the 510(k) process, without any evidence of clinical trials on the devices. Thousands of American women have suffered serious injuries from the devices. Roughly 100,000 lawsuits over pelvic mesh complications were filed in the U.S. alone. Even this staggering number is probably only a portion of the actual injuries.
Nevertheless, despite this fact, under the new approval process, the FDA will accept “greater uncertainty” in cases where gathering evidence before putting a device on the market would be impractical. The FDA will list the factors that will go into assessing “acceptable uncertainty,” the FDA says. The attorneys at TheLawFirm.com are convinced that this plan, however, will increase patient risk by putting medical devices on the market before their safety and effectiveness have been proven.
The current process, which we rail against, mandates that manufacturers may have to gather evidence of safety and effectiveness, conduct clinical trials or show that a device is “substantially similar” to one already on the market. The “substantially similar” route is called the 510(k) process, and our attorneys have regularly bashed this process for allowing dangerous or defective devices through the regulatory process.
The FDA website says that the “FDA recognizes that such direct comparison testing creates burdens for 510(k) applicants, especially when many new devices are designed in novel ways, using more advanced technologies”.
It isn’t just attorneys who are concerned with this process. The Institute of Medicine, part of the National Academies of Sciences, Engineering and Medicine reported in 2011 that “the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one”.
The institute suggested replacing the 510(k) process with a system that would gauge safety before putting medical devices on the market. The new FDA approval process does exactly the opposite: it takes the 510(k) concept even further. The FDA claims that the current system, which was created in 1976, “isn’t well-suited to reflect the innovation that we see today in certain technologies, and how we must evaluate those technologies.”
Thus, the new approval process could allow a new medical device on the market without having to compare it to a previously approved medical product, so long as it met certain other standards.
Under the FDA’s proposed framework, device manufacturers could demonstrate substantial equivalence by meeting safety and performance criteria through three pathways:
• FDA-recognized standards
• FDA-developed guidance documents
• A combination of the two which meet the safety and performance levels new devices have
to meet to gain 510(k) clearance
All of this would be more palatable if the current system was working to protect patient safety. But it doesn’t. The thousands of Americans injured by defective medical devices each year are a testament to that. Thus, the only possible reason for the new system is to give even more power and wealth to Big Pharma. Americans are now little more than guinea pigs for the profits of Big Pharma.
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