In the context of medical devices, the terms “listed”, “cleared”, “approved”, and “granted” all refer to a finding or status from the FDA that authorizes a device to be legally marketed and sold in the United States. As a result these terms tend to be used interchangeably, however they definitely don’t mean the same thing. Each references a unique pathway to market that is based on the device’s risk class. This article explores the differences between each term, and what level of FDA scrutiny/review they represent.
Owners or operators businesses that are involved in the production and distribution of medical or in vitro diagnostic devices (intended for distribution and use in the United States) are required to register their establisment annually with the FDA, using a process called establishment registration. This also requires to list the devices and the activities performed on those devices at that establishment. But before listing, you need to identify the proper classification of the device(s) to be listed.
The FDA uses three levels of classifications for medical devices with each carrying a different patient risk value. Once you have determined the correct classification category, you must then choose the proper registration pathway – Pre-Market Notification (otherwise known as 510(k)), Pre-Market Approval (PMA) or De Novo process. Before you can legally market your device in the US, it must be FDA cleared or approved or in the case of the De Novo process, granted.
Regulatory professionals have heard the terms registered, cleared, approved, and even granted used throughout the medical device industry, and even they are sometimes confused about the differences between them. However, the distinctions are significant, and it’s important to know the differences between these terms and understand how and when to use them.
Most Class I and some Class II medical devices are exempt from 510k submission requirements.
All other Class II devices require 510(K) clearance as a premarket submission to FDA to demonstrate that the device is as safe and effective. Clearance is based on the device being substantially equivalent to an existing, legally marketed device, that does not require premarket approval (PMA). Medical devices in the 510(k) category receive an FDA clearance to bring the device to market.
All Class III devices require a Pre-Market Approval (PMA) - the most stringent type of device marketing application required by FDA. Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Medical devices in this category receive an FDA approval to bring the device to market.
Novel devices that don’t have a predicate on the market are classified as Class III by default. However, companies can use the De Novo process to request that the FDA review the risk and safety information of the device for possible re-classification. When a De Novo request is granted the device is re-classified as Class II, and the device may be brought to market.
Companies can also submit a Humanitarian Device Exemption (HDE) application for Class III devices. 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 4,000 individuals in the United States per year. The (HDE) application is similar to a PMA application, but it is exempt from the effectiveness requirements of a typical PMA.
Terminology is only one of the things that can be confusing about the FDA’s processes. Using the wrong terminology can impact your company’s reputation, and possibly have some legal implications, but more importantly, it can mean that you don’t have a clear understanding of how to bring your product to market.
Making sense of the different FDA processes can be challenging—especially for companies that are bringing devices to the market for the first time. For a detailed walkthrough of the steps, documents, and timeline associated with each path to market, see our Beginner's Guide to the 510(k), and Beginner’s Guide to the FDA De Novo Process.