How Are Medical Devices Regulated?

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The pre- and post-market regulation of medical devices is somewhat of a grey area in the United States. Medical devices are subject to regulation, but in a different manner than other consumer products. They are meant to treat illness and injury and yet are not subject to the same stringent regulations as prescription and over-the-counter medication. This opens the door to some confusion when patients are seriously injured by the very devices that were meant to treat or improve their medical conditions.

In this blog, we will take a closer look at medical device regulation in the U.S., its impact on consumer safety, and how it's changed the ability of patients to come forward with lawsuits against manufacturers of medical devices that cause more harm than good.

A History of Medical Device Regulation in the U.S.

The Center for Devices and Radiological Health (CDRH) is responsible for the regulation of medical devices and radiation-emitting products in the United States. The Center operates under the Food and Drug Administration (FDA), which is the oldest government agency responsible for protecting consumers and promoting their health. The CDRH works to evaluate the safety and effectiveness of medical devices before and after they reach the U.S. market, applying regulations set forth by the Medical Device Regulation Act of 1976 (which were amendments to the Federal Food, Drug, and Cosmetic Act of 1938), the Safe Medical Devices Act of 1990, and others.

The Medical Device Regulation Act established a three-class system for all medical devices based on their inherent risk. It also required new medical devices and those that had significant modifications to get premarket approval from the FDA, and it authorized the FDA to ban certain devices that did not meet premarket approval requirements.

Medical devices are categorized as Class I, II, or III depending on the risk they pose to consumers:

  • Class III devices are considered to pose the highest risk and are subject to general regulation and premarket approval.
  • Class II devices are considered to pose a moderate risk and are subject to general and special regulation (when applicable).
  • Class I devices are considered to pose a low risk and are therefore subject to general regulation only.

The Safe Medical Devices Act went a step further, focusing on surveillance and recalls of medical devices after they reached the market. It authorized the FDA to require manufacturers to monitor permanently implanted medical devices that could cause catastrophic injury or death if they failed. It also required medical facilities like hospitals and nursing homes to report adverse events and reactions to medical devices. The Act gave the FDA the authority to order medical device recalls and impose fines and other civil penalties on manufacturers or others for violations of the Federal Food, Drug, and Cosmetic Act.

How the CDRH Approves Medical Devices

For Class I and Class II devices, the CDRH will approve their release if they show “substantial equivalence” to a legally marketed device. If the intended use, features, and testing are similar enough to a product that is already on the market, the CDRH approval process is relatively straightforward. For Class III devices, however, the process is more complex. The manufacturer is presenting a device that has not yet been marketed in the U.S. and must therefore provide reasonable assurance of its safety and efficacy.

Once the CDRH approves a medical device for release in the U.S., the regulations continue. Medical device regulations apply to labeling, the reporting of adverse reactions, registration with the FDA, testing and quality control, and branding. If a manufacturer, distributor, or other party involved in the production, distribution, or sale of a medical device violates regulations and the device causes harm, they’ll be subject to civil penalties. The device may also be recalled.

Why Regulating Medical Devices Is Important

The regulation of medical devices is important for a number of reasons. First and foremost is patient safety, as assessing the safety and effectiveness of medical devices before they are marketed is intended to prevent potential harm to patients. A rigorous review process helps identify and address potential risks and adverse effects that could compromise patient safety.

Beyond patient safety, the benefits of medical device regulation include:

  • Efficacy and performance: Regulating medical devices ensures that they perform as intended and deliver the desired therapeutic benefits. Regulatory agencies establish performance standards and requirements to assess the devices' effectiveness in treating or diagnosing medical conditions, leading to improved patient outcomes.
  • Quality assurance: Regulatory oversight helps maintain the quality of medical devices throughout their lifecycle, from design and manufacturing to distribution and post-market surveillance. This process includes monitoring device performance, tracking adverse events, and implementing corrective actions when necessary to address any safety or performance concerns that arise after a device is on the market.
  • Innovation and technological advancements: A well-regulated medical device industry encourages innovation and the development of new technologies that can benefit patients. Regulatory agencies aim to strike a balance between ensuring safety and promoting technological advancements, fostering an environment where innovative and effective medical devices can be brought to market.
  • Public trust: A robust regulatory framework helps build public trust in the safety and effectiveness of medical devices. When people believe that the devices they use are held to high safety and performance standards, they are more likely to follow their healthcare providers' recommendations and benefit from these devices.

Famous Medical Device Recalls in the U.S.

When dangerous medical devices make it to market despite regulations meant to ensure their safety and efficacy, they are subject to recalls.

Some of the most notable medical device recalls in the U.S. include:

  • DePuy ASR Hip Replacement System (2010): The DePuy ASR Hip Replacement System, manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics, was recalled in 2010 due to high failure rates. Over 93,000 devices were recalled worldwide, with approximately 37,000 in the U.S. The device had a higher-than-normal failure rate, with about 12% of patients requiring revision surgery within 5 years of implantation. Some patients experienced pain, swelling, and mobility issues, while others suffered from metallosis, a condition caused by metal debris from the implant entering the bloodstream.
  • Medtronic HeartWare Ventricular Assist Device (HVAD) System (2021): Medtronic initiated a Class I recall for its HeartWare HVAD System in 2021. The device, used in patients with advanced heart failure, had been associated with 29 deaths and over 19 serious injuries. The recall affected over 8,800 devices in the United States. Issues with the device included a delay or failure to restart after it was stopped, loose power and data connectors, and other design issues that led to serious adverse events.
  • Guidant Implantable Cardioverter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (2005): In 2005, Guidant Corporation recalled nearly 109,000 ICDs and CRT-Ds due to potential malfunctions that could cause the devices to fail. At least seven deaths were linked to the faulty devices. The recall affected 19 different models, and issues included short-circuiting and memory errors that could result in the devices failing to deliver life-saving shocks.
  • Baxter Colleague Volumetric Infusion Pumps (2010): Baxter International recalled all Colleague Volumetric Infusion Pumps in 2010 after the FDA identified serious safety concerns. Approximately 200,000 devices were affected in the United States. The recall was initiated due to various malfunctions, including battery swelling, low battery life, and software errors that could lead to over- or under-infusion of critical medications. The FDA received over 56,000 reports of adverse events related to the pumps, including at least 10 deaths and several serious injuries.

In all of these cases, medical devices made it to market and were used on patients who expected relief, treatment, and results—only to experience serious or even deadly side effects as a result. Medical device regulation is a step in the right direction, but it is not always enough to keep a defective, mismarketed, or poorly designed product off the market.

Harmed by a Medical Device? Talk to Our Attorneys.

If you or someone you love was harmed by a medical device, even one that was approved by the government, you deserve to have your voice heard. Our Pennsylvania medical device injury attorneys are ready to listen to your story and offer our insight regarding your rights and options. We hold manufacturers, medical professionals, distributors, and retailers accountable for releasing and selling products that injure patients.

Our team may be able to help you with a lawsuit involving:

  • A medical device that was used for something other than its intended purpose.
  • A device that was marketed for something other than what it was approved to treat.
  • A device that was improperly manufactured or designed, causing it to fail.
  • A device that was released without proper testing, trials, and quality control.

Manufacturers who violate medical device regulations can be held legally responsible for any resulting injuries. They can be sued for the cost of medical treatment, ongoing care, lost earnings, emotional trauma, pain and suffering, and even punitive damages. Injured patients and families who recover this compensation from at-fault parties can then get peace of mind in seeing justice served—plus the ability to rebuild and move on.

For a free, confidential review of your case, call (888) 498-3023 or contact us online.

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