FDA Approved vs. Cleared: What's the Difference, and Why Should You Care

Select FDA Approved vs. Cleared What’s the Difference, and Why Should You Care FDA Approved vs. Cleared What’s the Difference, and Why Should You Care

You’ve probably seen those little FDA labels on medical devices, from simple thermometers to high-tech implants. But have you ever wondered what those labels really mean? Is an FDA-approved device better than a cleared one? And does it even matter?

If you’re like most people, you probably don’t give it much thought. But understanding the difference between FDA approved vs cleared can help you make more informed decisions about the medical devices you use – and ultimately, your health.

Let’s break it down…

What is the FDA?

Before we get into the nitty-gritty, let’s familiarize ourselves with the FDA. The U.S. Food and Drug Administration is a federal agency responsible for safeguarding public health. They’re like the watchful guardians of the products we use and consume daily—everything from medications and medical devices to food and cosmetics.

The FDA is in charge of ensuring that medical devices are safe and effective for their intended use. They do this through a rigorous review process that evaluates the scientific evidence provided by manufacturers.

The FDA’s involvement doesn’t stop at approval or clearance. They continue to monitor devices after they’re on the market, watching for any safety concerns or adverse events. Think of them as your health watchdog, always on the lookout for potential risks.

What Products Need to be FDA Approved Or Cleared?

Not all medical devices undergo the same level of scrutiny. The FDA classifies medical devices into three categories based on their risk level:

  • Class I: These are low-risk devices, like bandages, examination gloves, and hand-held surgical instruments. Most Class I devices don’t require FDA review before they hit the market.
  • Class II: These devices pose a moderate risk. Examples include powered wheelchairs, infusion pumps, and X-ray machines. Class II devices typically require FDA clearance through a process called premarket notification (510(k)), which we’ll discuss later.
  • Class III: These are high-risk devices, such as pacemakers, heart valves, and implantable defibrillators. Class III devices require the most stringent level of FDA review – premarket approval (PMA).

It’s important to note that this classification isn’t set in stone. The FDA can change a device’s classification if new risks emerge or if its intended use changes.

What Does FDA Cleared Means?

FDA clearance doesn’t mean the FDA has tested the device themselves. Instead, it means the manufacturer has demonstrated that their device is “substantially equivalent” to a device that’s already on the market and considered safe and effective. This process is called premarket notification, also known as the 510(k) pathway.

The FDA reviews the manufacturer’s data, comparing the new device to a “predicate” device. If the FDA determines that the new device is as safe and effective as the predicate, they “clear” it for marketing.

What is FDA Granted?

For some low- to moderate-risk devices that don’t have a suitable predicate, the FDA offers a pathway called De Novo classification. This allows the FDA to classify a novel device and then clear it for marketing through the 510(k) process.

What Does an FDA-Approved Device Mean?

FDA approval is the gold standard for medical devices. It means the FDA has conducted a thorough review of the manufacturer’s clinical data and determined that the device is safe and effective for its intended use. This process, called premarket approval (PMA), is much more rigorous than the 510(k) process.

Manufacturers must submit extensive evidence from clinical trials, demonstrating the device’s safety and effectiveness in human subjects. The FDA also inspects the manufacturing facilities to ensure they meet quality standards.

Key Differences FDA Cleared Vs Approved Vs Granted


FDA Cleared

FDA Granted

FDA Approved

Risk Level

Class II

Class I or II

Usually Class III

Review Process

Premarket Notification (510k)

De Novo Classification 

Premarket Approval (PMA)

Evidence Required

Substantial Equivalence to Predicate

Safety & Effectiveness for Novel Device

Safety & Effectiveness with Clinical Data

Review Time

Typically Shorter


Typically Longer

The 510(k) Submission Process

The 510(k) submission process is how manufacturers obtain FDA clearance for their medical devices. Here’s a simplified overview of the steps involved:


  1. Determine Eligibility: The first step is to confirm that your device requires a 510(k) submission and doesn’t fall under any exemptions.
  2. Identify a Predicate Device: Find a legally marketed device (the “predicate”) that is substantially equivalent to your device in terms of intended use, technological characteristics, and safety/effectiveness.
  3. Prepare Your Submission: Gather and organize the required documentation, including:
    • Device description and labeling
    • Summary of technological characteristics
    • Substantial equivalence comparison to the predicate device
    • Performance testing data
    • Proposed indications for use
  1. Submit Your 510(k): Submit your 510(k) electronically through the FDA’s online portal.
  2. FDA Review: The FDA will review your submission, typically within 90 days. They may request additional information or clarification during this time.
  3. Decision: The FDA will either:
    • Clear your device for marketing
    • Issue a “not substantially equivalent” (NSE) letter, requiring more information or a different submission pathway
    • Reject your submission

Estimated Cost Range

The cost of a 510(k) submission can vary widely depending on the complexity of your device, the amount of testing required, and whether you use consultants or in-house staff. Here’s a general range to give you an idea:

  • FDA User Fees: The FDA charges user fees for 510(k) submissions, which can range from $4,967 for small businesses to $19,870 for standard submissions in 2023.
  • Testing Costs: Testing is often the most expensive part of the process. Costs can range from a few thousand dollars to hundreds of thousands, depending on the nature of your device and the required tests.
  • Consulting Fees: If you hire consultants to help with your submission, their fees will add to the overall cost.

Premarket Approval Application

The PMA application is a comprehensive document submitted to the FDA to demonstrate the safety and effectiveness of a high-risk medical device. It’s a complex process that typically takes about six months or more to complete. Here’s what you need to know:

Required Information

The PMA application must include a wide range of information, including:

  • Non-Clinical Laboratory Studies: Detailed reports on laboratory and animal testing to assess the device’s safety, performance, and potential risks.
  • Clinical Investigations: Comprehensive data from clinical trials involving human subjects, demonstrating the device’s safety and effectiveness in real-world scenarios.
  • Device Description: A thorough description of the device’s design, materials, components, and manufacturing processes.
  • Labeling: Proposed labeling for the device, including instructions for use, warnings, and precautions.
  • Risk Analysis: A detailed assessment of the potential risks associated with the device and how those risks will be mitigated.
  • Proposed Indications for Use: A clear statement of the medical conditions or diseases the device is intended to diagnose, treat, prevent, or mitigate.

Review Timeline

The FDA review process for PMA applications typically takes at least 180 days. However, it can take significantly longer, depending on the complexity of the device and the quality of the submitted data. The FDA may also request additional information or clarification from the manufacturer, which can further extend the timeline.

Obtaining FDA approval through the PMA pathway is a major milestone for medical device manufacturers. It demonstrates that the device has met the highest standards for safety and effectiveness, giving healthcare providers and patients confidence in its use.

FDA Registered vs. FDA Approved

While both terms relate to the FDA’s oversight of medical devices, they represent very different levels of regulatory scrutiny:

FDA Registered

  • Applicability: Applies to all facilities (manufacturers, re-packagers, re-labelers) involved in the production and distribution of medical devices in the U.S.
  • Process: Companies must register their establishments with the FDA and list their devices, providing basic information like company name, location, and device types.
  • Significance: Registration is a mandatory requirement for operating in the medical device industry, but it does NOT imply any evaluation of the device’s safety or effectiveness.

FDA Approved

  • Applicability: Applies to specific medical devices that have undergone a rigorous premarket approval (PMA) process. This usually includes high-risk devices (Class III) like pacemakers, heart valves, and implantable defibrillators.
  • Process: Manufacturers submit extensive data from non-clinical and clinical studies to demonstrate the device’s safety and effectiveness. The FDA thoroughly reviews this data and may inspect manufacturing facilities.
  • Significance: FDA approval is the highest level of regulatory oversight for medical devices and indicates that the device has met stringent standards for safety and effectiveness.

Final Words

In the end, knowing whether a medical device is FDA-cleared or approved can empower you to make smarter decisions about your healthcare. While both types of devices must meet safety standards, FDA approval signifies a more rigorous evaluation process, particularly crucial for high-risk devices. So, the next time you see those FDA labels, take a moment to decipher their meaning. It could make all the difference in your health journey.

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