An Overview on Medical Devices Law

Learn the basics of recalls and lawsuits

By Super Lawyers staff | Reviewed by Canaan Suitt, J.D. | Last updated on April 4, 2023

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If you use a medical device, you know how beneficial they can be. Unfortunately, sometimes the tools that are meant to help us can harm us instead. While you may have heard about recalled medical devices, or even class actions seeking a remedy for a common injury, you might be wondering if these issues apply to you and your device—and what you should do if you think you have been harmed.

You may have a number of legal options, and you might want to go over them with a lawyer. The following is a resource you can use to understand the basics of recalls and lawsuits so you can decide whether you should speak to a lawyer, and what to ask them if you do.


A medical device is any type of device intended for medical purposes. They can be as simple as a tongue depressor or scalpel, or as complex as pacemakers and artificial joints.

The U.S. Food and Drug Administration (FDA) is the federal agency responsible for regulating firms that manufacture or import medical devices in the United States. The FDA uses a regulatory framework that classifies medical devices in three categories:

  • Class I devices such as tongue depressors, oxygen masks, or scalpels
  • Class II devices such as blood transfusion kits, syringes, pregnancy tests
  • Class III devices are implantable devices or high-risk devices such as pacemakers and defibrillators

FDA regulations increase from Class I to Class III. For example, Class I devices generally don’t require premarket notification; Class II devices generally do require premarket notification; and Class III devices require premarket approval.

The Investigational Device Exemption (IDE) allows the device to be used in clinical trials in order for the manufacturer to collect safety data about the new device needed in the premarket approval application (PMA).

The FDA also engages in post-market surveillance to assess the device after its release in the market. Additionally, through its Quality System Regulation, the FDA sets good manufacturing practices for the methods and facilities used in producing medical devices, from designing to labeling.

Medications and drugs are not considered medical devices and are thus regulated differently. A defining characteristic of a medical device is that it does not accomplish its primary purpose through chemical reactions in the body.


When there is a problem with a medical device, medical device manufacturer notify the FDA through the Medical Device Reporting program (MDR). Companies or manufacturers will typically recall the product to correct or discontinue it. If the recalled device is an implant, it does not always need to be removed from the patient, but medical providers generally reach out to patients to discuss their options.

When the manufacturer recalls the device, the FDA then notifies the public. Legally speaking, the FDA can require companies to recall medical devices—but this is rare as companies generally do voluntary recalls. In the event that a company refuses to recall something that has been associated with serious problems or death, the FDA will force it to.


If you were injured by a medical device, you may consider bringing a personal injury lawsuit. Manufacturers can be liable for personal injury when:

  • The device was defective when it was manufactured
  • There are dangerous side effects
  • The device was improperly marketed

These cases would be brought under a products liability lawsuit. You might also be able to hold other parties liable including labs, sales reps, or providers, depending on the jurisdiction you are in and the parties’ roles in your injury.

Another legal route you can consider is a medical malpractice lawsuit. These cases allege that your medical provider did not act in accordance with the appropriate standard of care in the medical profession, leading to your injury. These cases are often brought against surgeons and their staff or the physician the prescribed the device that caused your injury.

Unfortunately, some medical device injuries can tragically lead to death. In these cases, spouses or heirs of the deceased can bring a wrongful death lawsuit. The parties in these suits will generally be the same as in the other types of cases discussed previously.

Common Questions for an Attorney

Below are some common questions you might want to consider when meeting with an attorney for the first time.

  1. What are your attorney’s fees and billing options?
  2. Which agency is responsible for my medical device regulation?
  3. How do I know if my medical device has been recalled?
  4. What do I do if I was harmed by a recalled device?
  5. Can I join a class action lawsuit?
  6. How do I know who was responsible for my injuries?
  7. What kind of damages can I recover?

Finding the Right Attorney for Your Needs

It is important to approach the right type of attorney—someone who can help you through your entire case. To do so, you can visit the Super Lawyers directory, and use the search box to find a lawyer based on your legal issue or location.

To help you get started, you may want to consider looking for a lawyer with experience practicing medical device law.

Why Should I Talk to a Lawyer?

If you were injured by a medical device, you will need to prove your case using medical records and by interviewing doctors, medical staff, and scientists. A lot of this information can be hard for a layperson to understand, and it can be beneficial to have an experienced lawyer involved in the process. Your lawyer will know how to get the records you need, the best legal case to bring, who you should interview, and what the applicable law and regulatory requirements are.

A lawyer will further be able to anticipate potential problems with your case and advise you on how to approach them, and they will also keep track of deadlines and file all the paperwork with the necessary courts and agencies—giving you one less thing to worry about.

What do I do next?

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