FDA Cleared vs. Approved: Does FDA Approval Mean a Product 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 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.

A specific issue that affects medical devices involves whether the product in question is FDA-cleared vs. approved. With medical devices, there is an opportunity for a manufacturer to get it FDA-cleared instead of FDA-approved, if it is similar enough to an already approved device. 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 1), medium-risk (Class 2), and high-risk (Class 3) categories. Class 1 devices are not intended to sustain or support life. Class 2 devices are those that must be safer than Class 1 devices but don’t sustain life. Finally, a Class 3 device receives the most rigorous testing because it is used to support life.

For example, the following devices fall into these categories:

• Class 1: Elastic bandages and hand-held surgical instruments
• Class 2: Powered wheelchairs, catheters, blood pressure cuffs, and infusion pumps
• Class 3: Heart valves, metal-on-metal hip joints, and other implants

The 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 PMA process consists of thorough studies on the device before it hits the market. This route is most often used for new or very-high risk devices and can be quite costly. While more thorough, the pre-market approval process requires resources and something many people don’t have for a much-needed medical device: time. Pre-market approval is the equivalent of FDA approval in the comparison of whether a medical device is FDA-cleared vs. approved.

The 510(k) Approval for Medical Devices

The 510(k) method is much simpler. It requires medical device manufacturers to present evidence that the device is equivalent to an existing device on the market. This approval process is most used for Class 1 and Class 2 devices since they have the lowest risk of causing severe or fatal injuries to users. This is the equivalent of FDA clearance in the comparison of whether a device is FDA-cleared vs. approved.

FDA Cleared vs. Approved

Some medical devices can get FDA clearance instead of approval before going to market. Class I and Class II medical devices may be FDA-cleared if the manufacturer can prove that they are similar to another device that already has been cleared or approved by the FDA. A company seeking FDA clearance must submit a 510(k) to the FDA so the product can be reviewed and cleared. If the FDA reviews the new medical device and decides that it is similar enough to an already approved or cleared device, it can be sold and marketed in the United States as an FDA-cleared device.

In short, many devices that are deemed low or medium risk may be FDA-cleared vs. approved—without extensive testing, and the extensive cost of thorough testing on high-risk devices leads many manufacturers to attempt to circumvent the PMA process. This can be detrimental to the unassuming consumer/patient, and require the legal help of a seasoned dangerous medical devices attorney.

Does FDA Approval Mean It’s 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 recalls of FDA-approved devices and products.

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

Headline-worthy recalls in the FDA’s past have ranged from a Medtronic defibrillator wire that was not tested in a clinical trial to faulty pelvic mesh devices that severely decreased the quality of life for thousands of women. Many cases are made worse by the fact that the devices cannot be removed without serious risk, as seen in the case of pelvic mesh implants and metal-on-metal hip implants that leaked toxic metal ions into patients’ blood. Though the FDA quickly took steps to take these products from the market, the damage was irreversible for many.

FDA Clearance vs. Approval Does Not Limit Your Right to File Suit

Even if the FDA cleared or approved a medical device, this does not limit your right to file suit. You can still take legal action against the manufacturer or other at-fault party for designing, creating, and selling a product that was ultimately unsafe for use. FDA approval does not give a company immunity from lawsuits filed by injured patients and their families.

You’ve Been Injured: What’s Next?

The FDA system is consistent in weeding out many hazardous devices. However, every system is faulty at some point. If you’ve been injured due to the defects of an FDA-cleared or approved medical device, Arnold & Itkin is ready to help. We focus on holding large companies accountable for failing to test products and, in some cases, releasing them despite knowing of their risks.

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.