Americans enjoy the benefits of extensive research with medical devices. Medical device manufacturers create a variety of devices to cure, fix, and support a variety of ailments. These devices can range from something as simple as a tongue depressor to something more complex like a medical implant device.
Such devices are regulated by the Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health (CDRH). The CDRH provides guidance documents for manufacturers looking to create or improve devices for medical use. As with all regulatory agencies, the FDA will allow a notice and comment period preceding the promulgation of any rules or regulations. During this period, anyone may comment on the rules. Typically, commenters may comment on unforeseen consequences of the rules, conflicting rules already in force, or any policy considerations that they feel the FDA might not have considered. The FDA can consider the comments and amend the proposed rule with another comment period or they may go ahead and promulgate the rule with an explanation to acknowledge they did consider the comments offered.
One important aspect of medical device regulation is with device tracking. If problems occur, a recall can happen more quickly because the manufacturer and the FDA will have access to the information. Tracking happens when a new device has been approved for marketing. The FDA has authority to continue to monitor the effects of the device for an unreasonable risk. After the period for tracking has ended, the FDA has an option to continue to track or to drop the product from the tracking list.
When there is a problem with a medical device, the area of law under which it falls will be product liability. In this area of law, an injured plaintiff may sue anyone in the product distribution chain, including the manufacturer, distributor and the seller. Because the devices will have a tracking record with the FDA, such information can be helpful evidence for any complaints. Those seeking relief will have to go through the administrative process. That process will be more like a trial and the FDA will issue a decision on whether or not relief is warranted. Those who do not agree with the relief can appeal through the court process. There is also an option of settling outside of the administrative process.
This article is for general informational purposes only and is not to be construed as legal advice. Do not rely on the above information as all cases are different and different laws apply to different cases. Consult an attorney in your area for further guidance.