Devices

The FDA has regulated medical devices since 1938 but with 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 provided the framework for our current regulatory system. That legislation was updated in 1990 and 1997.

Risk Categories 

Devices are put into one of three categories:

1. Low-risk devices—Low-risk devices are not tested. These include items such as band-aids, tongue depressors, and crutches.
2. Moderate-risk devices–  90-95 percent of devices on the market are categorized as moderate-risk devices. This category includes items such as glucose meters, contact lenses, and solutions, some of which can be purchased over the counter. However, class 2 also includes devices that require invasive surgery to be implanted and removed. Some examples include the hardware used to treat spinal issues and hip and knee joint replacements. Class 2  devices do not require any clinical trial testing. This means that  90-95% of medical devices are never tested for safety and effectiveness because they are cleared for the market through a fast-track process known as the 510(k).
3. High-risk devices—High-risk devices must be life-saving or life-sustaining and include devices such as artificial heart pacemakers. However, this category also includes breast implants. Any device in this category requires only one clinical trial as part of the premarket approval process. The testing must provide evidence that the device is reasonably safe and effective.  

Market Pathways

1. Premarket Approvals Clinical trials of category three high-risk devices are required when no predicate device is 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 one clinical trial does not include a broad enough demographic or is undertaken 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 Premarket Notification) of the Food, Drug, and Cosmetic Act requires registered device manufacturers 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 enter the 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 market clearance is one of substantial equivalency to a previously cleared device 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 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 premarket screen of safety and effectiveness of moderate-risk devices and 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 cohesively. Until the current system is replaced with something that serves the public’s best interests, it is essential to remember that newer is not always better;  faster does not make a device safer.

Medical Device User Fee Amendments (MDUFA)

The Medical Device User Fee and Modernization Act established device user fees in 2002. 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.