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FDA Cleared vs. Approved

When talking about US regulatory pathways for medical devices, terms like clearance, approval, and registration often intertwine, leading to confusion among stakeholders. A fundamental understanding of these terms is important for navigating the intricate landscape of bringing medical devices to the US market under FDA oversight. This article aims to dig into these concepts, elucidating their meanings, applications, and significance when it comes regulatory compliance.

What are the different application possible to bring medical devices to the US market?

The US Food and Drug Administration (FDA) serves as the gatekeeper for medical devices entering the US market, dictating the pathways for their approval or clearance based on their risk classification. These pathways include:

  • 510 (k): A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.

  • Premarket Approval (PMA): PMA is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.

  • Humanitarian Device Exemption (HDE): the US regulation also provides for the submission of a HDE application. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 8,000 individuals in the United States per year. The HDE application is similar in both form and content to a PMA application, but is exempt from the effectiveness requirements of a PMA.

  • De Novo: The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option, which is also known as Evaluation of Automatic Class III Designation. This option provides an alternate pathway to classify novel devices of low to moderate risk. Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

What does 'FDA approved' mean?

"FDA Approved!" can be found in many different websites. But what does that really mean? And what can be approved by the FDA?

FDA approval means that the product has gone through the PMA process or are considered a HDE. As stated before, Premarket Approval means a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. This is generally only applicable for high risk devices (Class III) and HDEs and is the most stringent pathway in the US. The database for products that have undergone premarket approval can be found here. A separate database for HDEs can be found here

The focus of this article is on medical devices, but also new human drugs and biological products need to pass premarket approval in order to be put legally on the US market.

What cannot be approved by the FDA?

The FDA does not “approve” health care providers, including physician offices, or laboratories. The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.

Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently.

What does 'FDA cleared' mean?

FDA clearance refers to the 510 (k), also known as Premarket Notification, pathway. This means that the device has been shown to be substantially equivalent to another legally marketed device. This is usually applicable to low to medium-risk devices (Class I and II), A database with 510 (k) cleared devices can be found here.

A device that has gone through the 510 (k) Premarket Notification pathway is "FDA cleared". You can learn more about the Software Validation Documentation with the FDA in our latest video.

What does 'FDA granted' mean?

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.

Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, when applicable.

An approved De Novo request is "FDA granted". A database of approved De Novo requests can be found here.

What about "FDA registered"?

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA.

Entry in the FDA's registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.


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About the Author
Ann Vankrunkelsven
RA/QA Manager