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.

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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