The FDA has been regulating medical devices since it was given the authority to do so by the Medical Device Amendments of 1976. However, the level of regulation that the FDA performs is not the same for all medical devices. Oftentimes, people have a different impression of the level of FDA involvement with a medical device than actually exists in reality,
There Are Three Risk Categories
The FDA divides medical devices into three different categories based on the risk that they pose. You should know what each class is and how it affects the level of regulation. Here is a little more information on each.
Class III High Risk – These are devices that, if they fail or are defective, can cause great harm to the recipient of the device. These devices must be approved by the FDA through something that is called pre-market approval. This is a very rigorous review process that will take time for the device to gain approval. When you think of stringent FDA review, this is generally the process that you think of. This includes devices such as pacemakers and artificial heart valves. This category comprises only about ten percent of the medical devices that are on the market.
One important note that you need to be aware of is the fact that a pre-market approval process will affect your ability to legally recover for a defective medical device. If the FDA has approved the device through the pre-market approval process, it is difficult for a plaintiff to financially recover in state court from the manufacturer for any damages suffered. When it comes to these devices, federal law preempts state law.
Class II Medium Risk – Most medical devices will fall into this class. They will support or sustain human life, but life will not necessarily depend on them. There is some possibility for harm to those who use the devices if they malfunction. Examples of this can be a powered wheelchair or a home pregnancy test. Class II medical devices do not need the same level of pre-market approval as Class I devices.
Class II devices will generally require something that is known as premarket notification. Manufacturers must make a filing with the FDA before they can sell the device to the general public. The notification requires that the manufacturer warrants that the product is safe and effective. It must also show that the medical device is substantially equivalent to a medical device that is legally marketed.
Class I Low Risk Devices – These are the medical devices that pose a low to moderate risk to the consumer. Roughly half of the medical devices on the market carry this designation. Class I devices are largely exempted from the regulatory process. If a device falls into this category, there is no notification or application to the FDA that is necessary before the manufacturer can sell the product to the public. The product will still need to be registered. If there is a malfunction with the Class I medical device, the manufacturer can be held liable civilly for any damages that the product causes.
Approved Is not the Same as Cleared
Some manufacturers will market their products as FDA-approved. However, to be approved by the FDA is a legal term that denotes a stringent review process. This is generally fulfilled by Class I devices only. Devices that are not FDA-approved are known as cleared by the FDA. This means that the device manufacturer has made a showing that the product is substantially similar to one that has been approved. This does not mean that the FDA has tested this product and made a pronouncement that it was safe and effective. It does mean that the manufacturer is making this assertion to the FDA based on their own testing and the fact that the device is similar to another device.
Devices that have been cleared cannot be marketed as being FDA approved. Some device makers have faced legal liability for making this representation. If a device maker induces others to purchase their product based on this false representation, they can be found legally liable if they are facing a lawsuit for this.
FDA Approval or Clearance Is not the End
Even after the product has been approved or cleared by the FDA, manufacturers still have a myriad of rules with which they must comply when they sell their products. This includes restrictions on advertising and marketing. There is also an obligation for ongoing surveillance of products that are sold. Moreover, if there are reports of injuries connected with a medical device, the FDA may order the device maker to perform additional testing. However, there have also been gaps in post-market surveillance of medical devices. Oftentimes, there is no intensive study of a possible defect until there is a preponderance of evidence that the product is causing harm after thousands of reports of complications. Therefore, it is often unrealistic to expect the FDA to continuously keep the public safe from defective medical devices. The FDA generally only steps in after there have been numerous reports of a problem.
FDA Regulation Is not Perfect
The FDA has faced criticism over the years for not subjecting more medical devices to the more stringent pre-market approval process. In fact, the United States Government Accountability Office has included FDA medical device regulation on its “High-risk” list for the past decade since it believes that the FDA has not taken steps to adequately regulate these medical devices. According to GAO, the FDA struggles to keep up with advances in the medical devices segment. This means that there are potentially dangerous devices that have been placed on the market that have not been tested to the extent that they should. Since there is no pre-market approval process, device makers are liable in state court for financial damages if the product harms consumers.
At the same time, the FDA makes many of its decisions behind closed doors and does not always adequately inform customers of the basis for its decisions. The combination of industry that has many options to lighten their regulatory burden and a government agency that does not always regulate vigorously leaves patients at risk for harm. The Law Offices of Sadaka Associates handles many types of cases in which people area injured from medical devices. They can help you navigate the process.