The Role of the FDA in Your Safet

A medical device is a product or instrument that aids in treating or diagnosing disease. This broad definition encompasses everything from digital thermometers to artificial hearts. The United States Food and Drug Administration (FDA) aims to protect public health by “ensuring the safety, efficacy, and security” of medical devices.

First, the FDA sorts medical devices according to risk and level of regulatory control necessary:

  • Class III: Items carrying the highest risk, often because they are necessary for sustaining or supporting life or they pose an unreasonable potential risk of injury or illness (e.g. mechanical heart valves, implantable infusion pumps, pacemakers, breast implants)
  • Class II: Moderate-risk medical devices (dialysis equipment, catheters, wheelchairs)
  • Class I: Minimum risk items like enema kits, manual breast pumps, and elastic bandages
  • Class I Exempt: Items of this class are low risk and are exempt from premarket and FDA approval, but they must meet general controls, and manufacturers must register their products with the FDA; examples might include manual stethoscopes, bedpans, and exam gloves

The FDA also reviews some products for safety and quality to ensure they are ready for use. In general, premarket approval is not required for Class I medical devices, which comprise about 47 percent of the market.

Class II devices are regulated if they are substantially different from other items already being sold. However, these products might need to meet specific controls or labeling procedures to warn users of potential hazards.

Class III devices are almost always subject to extensive testing. Manufacturers must “demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.”

These premarket approval processes can weed out faulty items, but they are not required for every product. Unfortunately, some defective products make their way into hospitals, clinics, and personal homes.

Why Some Medical Equipment is Dangerous

Manufacturers spend hundreds of thousands of dollars annually on developing and testing new products. Equipment and devices that carry a high potential of severe injury should never reach consumers.   Though designers and manufacturers must assess the safety of their products, eliminating all risks might not be possible. They must decide whether the potential benefits outweigh the probability and severity of unwanted side effects.

Yet, abandoning a project after investing large amounts of money in it is not easy for manufacturers. Unethical companies might release hazardous items to the public despite the risks.

There is no way to get around a potential hazard in other cases. These moderate-to-high-risk items must meet the general controls of:

  • Annual registration with the FDA
  • Listing their locations and devices manufactured at each establishment
  • Labeling (warnings, intended uses, and instructions)
  • Good manufacturing practices result in devices “suitable for use or capable of functioning”

Next, items are subject to premarket notification and approval. Clinical studies often provide evidence of the safety and effectiveness of novel products. Products must comply with FDA inspections related to:

  • Designing
  • Purchasing
  • Manufacturing
  • Packaging
  • Labeling
  • Storing
  • Installing
  • Servicing

Even with the checks and balances, injuries and deaths indicate that defects are not always predicted, detected, or repaired as they should be. The FDA has the authority to regulate what happens when issues arise. There are times when the manufacturer must correct issues or recall the product.

A product might be recalled if it:

  • Causes serious injuries or deaths
  • Causes illnesses or medical conditions
  • Violates FDA regulations

As a patient or relative seeking help from the medical profession, you deserve the best of care.

Medical Device Failures Are Unfair to Patients

Judd Shaw Injury Law’s medical device attorneys know that some product-related accidents are preventable. Those in the design, manufacturing, and distribution chain can be liable for defective medical devices.


Careless designs or production practices can cause defects. Manufacturers or distributors could fail to warn doctors or patients of potential risks. Suppliers could provide defective parts that ruin the function of a device that would otherwise work correctly.

Strict liability

In strict liability cases, lawyers do not need to prove negligence. Instead, they show that the product caused unexpected harm despite its proper use by the patient or physician.

Contact our product liability team if you or a loved one experienced health issues resulting from:

  • Artificial joints
  • Brain mapping software
  • Pacemakers
  • Pelvic mesh
  • Insulin and infusion pumps
  • Embolization devices
  • Septostomy catheters
  • Recalled medical products and equipment

Liability laws are not easy to understand. Our experienced lawyers can determine whether you have a case. Call (866) 909-6894 any time of day or night for a free consultation.

What Maximum Compensation Looks Like

Did you experience any of the following losses as a result of medical device failure?


Problematic medical devices can damage a patient’s body or worsen pre-existing injuries. Many injuries and conditions, including those listed below, can impact a victim’s quality of life:

  • Amputation: The loss of a part of the body, such as a limb, eye, ear, or other appendages
  • Bruises: Painful or swollen marks caused by crushed blood vessels
  • Burns: Tissue damage caused by heat, chemicals, electricity, or radiation, often accompanied by swelling, blistering, and scarring
  • Dislocated bones: When bones come out of their proper place in the joint, they can cause pain and an increased likelihood of dislocating the same joint again
  • Electrical injuries: Organ, nerve, or muscle damage precipitated by electrical current, burns, abnormal heart rhythms, and cardiac arrest
  • Fractures: Broken or crushed bones that could lead to deformities, lingering pain, and problems in mobility
  • Inflammation: Swelling resulting from injury, infection, or other causes
  • Sprains and strains: Injuries to the bands of tissue that connect bones and muscles
  • Traumatic brain injury: Head injuries that damage the skull or brain, often associated with loss of consciousness, motor control, and memory
  • Wounds: Cuts, scrapes, scratches, and punctured skin

During your free case review, you can tell us about your injuries and how they affect your daily routine.

Medical bills

Treating injuries, especially if you need long-term care, comes at a steep price. As part of a liability claim, you can seek reimbursement for your medical expenses, including:

  • Hospital and doctor visits
  • Laboratory tests
  • Prescription drugs
  • Adaptive devices like crutches, wheelchairs, and artificial limbs
  • Transportation (Emergency or travel for medical appointments)
  • Physical therapy
  • Surgeries
  • Aftercare

Every case is different, so you will need to talk to us to discover your eligibility for medical compensation. However, we aim to ensure you receive the necessary funds for life-saving treatment of your device-related health conditions. Our representatives at 1-866-909-6894 are always available to take your call.

Lost wages

You might not be able to work, either temporarily or permanently, after an accident. If so, you could qualify to recover the money you would normally have earned had you not been injured. You can also get reimbursed for vacation days, leaves of absence, and unpaid time off you used for recovery.

You can also seek damages for your lost earning capacity. Due to a disability, you may never be able to do the same type of work. Filing a claim for lost potential wages can help secure your financial future.

Wrongful death

In the unfortunate event that a loved one dies because of a defective medical device, our law firm wants to equip you to provide a dignified memorial service. Our lawyers can pursue funeral and burial costs on your behalf. Surviving dependents or spouses could qualify for additional compensation for loss of companionship, affection, and guidance.

Would you like to learn how compensation can lift your financial burden? We can help.

Benefit From the Judd Shaw Way

Will I ever get justice? Is it worth it to pursue a legal claim? If you are like other medical accident victims, such questions can rob you of your peace of mind.   Our compassionate lawyers want to put you at ease while we strive to obtain the best possible results for you. We call it “The Judd Shaw Way.” You can expect quick answers to your questions, personalized attention, and frequent contact from our team, so you always know what’s going on with your claim.

Experience our high-quality client services for yourself. Click the chat icon below to speak to a representative right now, or contact us at your earliest convenience. We look forward to assisting you.