FDA Cleared vs. Approved: Does FDA Approval Mean a Medical Device Is Safe?

The United States is home to the largest medical device market in the world. Chances are, you or a loved one rely on a medical device to some degree in order to maintain your quality of life. To create accountability for medical device producers, the Food and Drug Administration (FDA) has an approval process designed to check the safety of products. Besides checking if the claims of manufacturers are accurate, the FDA tests products to make sure they are safe and ready for use by consumers.

Often, FDA approval is a sign that a product has been rigorously reviewed and tested for safety. As a result, people assume that an FDA-approved medical device is safe for them to use. Unfortunately, this is not always the case. Sometimes, the FDA’s approval process allows unsafe products to make their way onto store shelves—or into the hands of medical providers and patients.

With medical devices, there’s another layer of complexity. In addition to being FDA-approved, medical devices can be FDA-cleared if the device is similar enough to an already approved device. In other words, if a similar medical device already exists, and that device has been approved by the FDA, the original medical device can bypass the approval process.

Let's take a closer look.

How the FDA Classifies Medical Devices

When processing applications for new medical devices, the FDA classifies entries into low-risk (Class I), medium-risk (Class II), and high-risk (Class III) categories. Class I devices are not intended to sustain or support life. Class II devices are those that must be safer than Class I devices but don’t sustain life. Finally, a Class III device receives the most rigorous testing because it is used to support life.

For example, the following devices fall into these categories:

• Class I: Elastic bandages and hand-held surgical instruments
• Class II: Powered wheelchairs, catheters, blood pressure cuffs, and infusion pumps
• Class III: Heart valves, metal-on-metal hip joints, and other implants

These different classes are subjected to varying degrees of trial and study before hitting the market. Certain devices, regardless of class, are approved by the FDA through either pre-market approval (PMA) or 510(k) reviews.

Pre-Market Approval for Medical Devices

The pre-market approval (PMA) process is the FDA’s most rigorous pathway for evaluating medical devices. It’s typically reserved for Class III medical devices, which include those that sustain or support life, are implanted in the body, or present a high potential for risk if they fail. These include products like pacemakers, heart valves, breast implants, and deep brain stimulators. Because these devices carry such serious risks, the FDA requires manufacturers to provide extensive evidence of their safety and effectiveness before they can be marketed to the public.

What the PMA process entails:

• To obtain pre-market approval, manufacturers must submit a PMA application, which includes a combination of clinical trial data, laboratory testing, engineering analyses, and manufacturing information.
• Human clinical studies are often a central component, and these must be conducted under strict FDA oversight through an Investigational Device Exemption (IDE).
• The data must demonstrate that the device provides a reasonable assurance of safety and effectiveness for its intended use.

This process can take several years and cost millions of dollars, depending on the complexity of the device and the quality of the data submitted. The FDA reviews not only the clinical outcomes but also the way the device is manufactured, labeled, and packaged. They may also inspect the manufacturing facility before approval is granted.

Is a Product Safe If It Has Pre-Market Approval?

While pre-market approval (PMA) is the most stringent pathway to FDA approval available, it does not guarantee a device is risk-free. It simply means the device met the FDA’s standards at the time of review, based on the data the manufacturer provided. In reality, devices approved through the PMA process have still been known to cause serious harm, especially when companies downplay known risks or fail to update the FDA with post-market data. In some cases, dangerous complications only emerge after a device has been widely used.

Another common issue with PMA is the time and cost involved. This can create barriers, particularly for patients waiting on innovative treatments, as some devices may be delayed for years, even if they could be life changing. As a result, the pressure to accelerate access sometimes leads to shortcuts or approval of devices with limited testing, increasing the potential for harm.

Ultimately, while pre-market approval is considered the "gold standard" of FDA oversight, this approval is not an ironclad guarantee of safety. This distinction becomes critical when patients are harmed by a device that was supposedly “FDA-approved.” Just because a product made it through PMA doesn't mean it was designed, manufactured, or marketed responsibly—and that's where personal injury law can play a vital role in holding manufacturers accountable.

What Is the 510(k) Approval Process for Medical Devices?

The 510(k) process, also known as pre-market notification, is a significantly less rigorous route than pre-market approval (PMA). Rather than proving a new device is safe and effective through independent clinical trials, manufacturers using the 510(k) pathway only need to demonstrate that their device is "substantially equivalent" to another legally marketed device, referred to as a “predicate device.” In other words, the new device doesn't need to undergo extensive testing if it appears to be similar enough to something already on the market.

This method is primarily used for Class I and Class II medical devices, which the FDA considers to be lower risk. Examples include bandages, thermometers, surgical gloves, catheters, and certain types of diagnostic tools or implants. However, some Class II devices can still pose serious health risks if they malfunction or are poorly designed.

How the 510(k) approval process works:

• To obtain FDA clearance through 510(k), a manufacturer must submit documentation comparing the new device to a predicate device in terms of:
  • Intended use
  • Materials
  • Design
  • Energy used or delivered
  • Technological characteristics
• If the FDA agrees that the new device is similar enough, it will issue a clearance—not an approval—allowing the product to enter the market.

The 510(k) process is faster, cheaper, and less demanding than PMA. In many cases, manufacturers can secure clearance in a matter of months, often without submitting any new clinical data. This is why the majority of medical devices in the U.S. are cleared through this pathway.

Concerns with 510(k) Clearance

The relative ease of the 510(k) route raises serious concerns about patient safety. Because it relies heavily on comparisons to older devices, it can create a “daisy chain” effect, where a new device is cleared based on a device that was itself cleared based on an even older product. Over time, the newer device may differ significantly from the original predicate, yet it still enters the market without undergoing rigorous safety testing. In fact, some devices cleared through 510(k) have been linked to serious injuries, complications, and recalls, despite having received FDA clearance.

One notorious example is the clearance of certain transvaginal mesh implants, which were cleared through the 510(k) process based on older predicates. These devices caused debilitating injuries in thousands of women and were later subject to FDA warnings and market withdrawals—but only after widespread harm had already occurred.

It’s important for consumers and patients to understand that FDA clearance is not the same as FDA approval. Clearance through 510(k) does not mean the FDA has thoroughly reviewed the device for safety or effectiveness. It simply means the agency has allowed it on the market based on similarities to an existing product. For those harmed by a defective or dangerous medical device, the fact that it was “FDA-cleared” often provides little protection or reassurance. That’s why holding manufacturers accountable through legal action remains essential when safety is compromised.

Does FDA Approval Mean a Product Is Safe?

Most people associate FDA approval with safety, assuming that any medical devices or other products that have been approved or cleared by the FDA are safe to use. This is, unfortunately, not always true.

Congress determines what products the FDA must approve and how the process works. Some products do not require FDA approval at all, some are reviewed after they are already on the market, and some have dangers or defects that are unknown to the FDA at the time of approval. This explains the countless recalls of FDA-approved devices and products we see every year.

FDA approval means that the agency’s experts have reviewed the information they were given regarding a product’s safety, quality, and effectiveness. If they were given false or misleading information about a product itself, clinical trials, or test results, this could skew the agency’s findings.

Notable FDA-Approved Device Recalls

Despite the FDA’s role in regulating medical devices, some of the most dangerous and devastating health crises in recent history have involved products that were either FDA-approved or FDA-cleared. These devices were marketed as safe, often aggressively promoted by manufacturers, only to later cause severe harm to thousands of patients.

Some notable medical device recalls include:

• Medtronic Sprint Fidelis Defibrillator Leads: One of the most infamous examples is the Medtronic Sprint Fidelis defibrillator lead, a wire that connected an implantable cardioverter-defibrillator (ICD) to a patient’s heart. Approved through the FDA’s PMA process, this wire was not subjected to adequate clinical testing before approval. After being implanted in over hundreds of thousands of patients, the wire was found to have a risk of fracturing, delivering unnecessary electrical shocks or failing to shock the heart when needed. In 2007, Medtronic recalled the device after at least five deaths were linked to the defect. Unfortunately, by the time of the recall, thousands of patients were already at risk. Removal was complex and dangerous, meaning many patients had to live with the faulty device inside them or face risky extraction surgeries.
• Transvaginal Mesh Implants: Another case involved transvaginal mesh implants, used to treat pelvic organ prolapse and stress urinary incontinence in women. Cleared through the 510(k) process by claiming substantial equivalence to earlier surgical mesh products, many of these implants were not tested in human clinical trials. After being implanted in hundreds of thousands of women, the mesh was linked to chronic pain, organ perforation, infection, and erosion into surrounding tissues. Many of these complications were irreversible, as the mesh integrated into the body’s tissues and could not be safely removed. In 2019, the FDA ordered manufacturers to stop selling certain types of pelvic mesh, acknowledging that the risks outweighed the benefits.
• Metal-on-Metal Hip Implants: A similarly catastrophic example is the case of metal-on-metal (MoM) hip implants, such as the DePuy ASR XL Acetabular Hip System, which was recalled in 2010. Marketed as a durable solution for younger, more active patients, these implants shed tiny particles of cobalt and chromium as the metal components rubbed together. This led to metallosis, a condition caused by toxic metal ions leaking into the bloodstream, causing tissue death, bone loss, and systemic health issues. Though these products were cleared under 510(k), the consequences were devastating. Johnson & Johnson, the parent company of DePuy, was ultimately ordered to pay billions in settlements after facing numerous lawsuits.
• Essure Birth Control Device (Bayer): Approved via PMA, Essure was a permanent birth control implant intended to block the fallopian tubes. Over time, it was linked to chronic pain, device migration, allergic reactions, and unintended pregnancies. The FDA added a black box warning in 2016, and Bayer withdrew it from the market in 2018. Lawsuits revealed that the manufacturer may have withheld adverse event reports from regulators.
• Bair Hugger Surgical Warming Blanket (3M): Used to regulate body temperature during surgery, this device was implicated in deep joint infections in hip and knee replacement patients. Though FDA-cleared, numerous lawsuits claimed the device allowed bacteria to enter open surgical sites. While it has not been formally recalled due to infection risks, it remains controversial and highlights the limitations of FDA clearance in identifying long-term risk.

These cases demonstrate a critical truth: FDA approval or clearance is not a final stamp of safety. Whether a device passes through the stringent PMA process or the faster 510(k) route, the system ultimately depends on the integrity of manufacturers to disclose known risks and on the FDA to take timely action. Unfortunately, in many cases, the harm to patients occurs long before recalls are issued, and, often, the damage is permanent.

Can You Sue If You Were Injured by an FDA Approved Device?

Yes, even if the FDA cleared or approved a medical device, this does not limit your right to file a lawsuit if you were harmed or if your loved one died as a result of using or receiving the device. You can still take legal action against the manufacturer or other at-fault party for designing, creating, and/or selling a product that was ultimately unsafe. FDA approval does not give a company immunity from lawsuits filed by injured patients and their families.

Were You Harmed by a Defective Medical Device?

While the FDA is able to weed out many hazardous devices, it cannot and does not catch every unsafe product. If you or someone you love was harmed by a defective medical device, even one that received FDA clearance or approval, Arnold & Itkin is ready to help. We focus on holding large companies accountable for failing to test products and, in some cases, releasing them to the public despite knowing their risks. Our firm has recovered billions for the injured, and our product liability lawyers are dedicated to helping patients and families get the justice they deserve.

Questions about whether a device was FDA cleared versus approved and how this might affect your right to recovery? Call our defective medical device lawyers now at (888) 493-1629. An initial consultation with our team is free, so you can discover what options are available to you.