The FDA has been regulating medical devices since 1938 but with very little oversight. By the 1970s the system could no longer adequately regulate the growing number of types and complexity of devices, so in 1976 Congress passed legislation that provides the framework for our current regulatory system. That legislation was updated in 1990 and 1997.
Devices are put into one of three categories:
Clinical trials are required of category 3 high-risk devices when there is no predicate device on the market. To meet the requirements for approval to market, the device company must conduct only one clinical trial. The concern for patients is that if the one clinical trial does not include a broad enough demographic, or if conducted only for a short time the results cannot provide efficient reasonable assurance of safety and effectiveness for use in the general public.
2. 510(k) Clearances
Section 510(k) (also known as Pre-market Notification) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify the FDA of their intent to market a medical device at least 90 days in advance. This allows the FDA to determine whether the device is substantially equivalent to a device already placed into one of the above categories.
Most medical devices make it to market after a 290 day 510(k) clearance process. Medical device makers want that fast-tracked to 108 days by 2022. For a De Novo submission (or a novel or new medical device), that time would be extended to 150 days.
The 510(k) looks at lab outcomes on paper and compares them to previously cleared devices. It does not look for the process by which those results were obtained. Medical devices are not tested for safety and effectiveness. The measure used for clearance to market is one of substantial equivalency to a previously cleared device – one that went through the same faulty system and was never tested for safety and effectiveness.
The FDA currently does not have the power to require a medical device maker to fix a defective design flaw that can injure consumers. A flawed medical device can still serve as a “predicate” upon which subsequent devices are cleared.
Public Citizen wrote a comprehensive report called Substantially Unsafe that explains how this process leads to patient harm. In addition, in a 2011 FDA-commissioned report from the Institute of Medicine the committee concluded that “the 510(k) process lacks the legal basis to be a reliable pre-market screen of safety and effectiveness of moderate-risk devices and furthermore, that it cannot be transformed into one”. However, the committee suggested that “the continual use of many of these devices in clinical practice provides reasons for a level of confidence in their safety and effectiveness”. The problem with that assumption is that the United States does not have a well-established method of tracking devices, reporting harm, or collecting those reports in a cohesive way. Until such time that the current system is replaced with something that serves the public’s best interests, it is important to remember that newer is not always better; faster does not make a device safer.
Medical Device User Fee Amendments (MDUFA)
Device user fees were established in 2002 by the Medical Device User Fee and Modernization Act. These fees are paid to the FDA to review applications submitted by companies wishing to market a medical device. The caveat is that 95% of devices are fast-tracked through the clearance process.
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