FDA approved vs. cleared vs. registered and what it means for your medical device
The Food & Drug Administration (FDA) is a familiar entity for most people in the U.S., and certainly those within medical device companies. But what you may not be as familiar with is the different types of endorsements the FDA awards. There are small but significant differences between terminologies that are FDA approved vs. FDA cleared vs. FDA registered. While the general public may use these terms interchangeably, the FDA certainly does not.
In order to understand these endorsements and their role in the medical device industry (just one of the multiple industries regulated by the FDA), it’s important to first review the FDA’s classification system. A medical device will be classified as Class I, II, or III depending on its risk profile. Whether you’ll need to pursue FDA registration vs. clearance vs. approval will depend on the classification of your devices and whether they are substantially equivalent to a predicate (more on that later in this blog post).
- Class 1 | Minimal risk to the user (like face masks, tongue depressors, etc.)
- Class 2 | Medium risk to the user (like wheelchairs, medical wearables, certain implants)
- Class 3 | Most risk to the user (like pacemakers, valve replacements, and other devices that are implanted into the body or used to sustain life)
What does FDA registered mean?
Required for: All medical devices of all classes. (This is actually a term independent of a specific device, but relates to the company.)
All medical device companies, regardless of the consumer risk posed by their devices, must register with the FDA in order to commercialize in the United States. Marketing a medical device without FDA registration is not only dangerous for consumers, but illegal. To determine if you need to register with FDA, read this guidance here.
Mandatory registration allows the FDA to monitor the entire medical device landscape and efficiently link complaints or adverse events recorded through MedWatch to companies for mitigation. You can access the full list of registered FDA medical device manufacturers here.
Registration is separate from submitting technical documentation for a specific device and it does not come with clearance or approval, both of which require more extensive application and FDA review.
What does FDA cleared mean?
Required for: most Class II devices with a predicate
FDA clearance is granted to Class II medical devices that can prove substantial equivalence to a previously approved or cleared medical device, or “predicate.”
When the FDA initially categorized devices into classes in 1976, they actually based those categories on an existing list of devices. Their goal was to streamline future device approvals, as companies that could prove substantial equivalence—in other words, that their device was practically the same as an existing, approved device—could secure regulatory approval on that basis without conducting further safety and efficacy trials. In fact, every Class II product sold in the United States today can trace its lineage back to a product that was on the market in 1976.
Medical device companies can achieve FDA clearance for Class II devices through 510(k) premarket notification. While the premarket notification process is still a substantial undertaking, it does not mandate rigorous, comprehensive safety and efficacy testing (such as human trials)—unlike the much more intensive PMA process for Class III devices.
Kapstone regulatory consultants are equipped to guide, manage, or fully take over 510(k) submissions in the United States, including preparation and submission of all necessary documents. These submissions do not need to be a barrier for medical device companies. With our assistance, you can trust that your device is in the hands of experts with decades of experience and familiarity with the latest regulatory guidelines.
What about the De Novo pathway?
Normally, devices without a predicate are automatically classified as Class III. However, the De Novo pathway may be an option for devices that do not have a predicate but can be proven to fall into Class I or Class II.
There are two options for when you can submit a De Novo request:
- If and when your device undergoes 510(k) review and the FDA decides that it is not substantially equivalent (NSE) to a predicate device
- In lieu of a 510(k) submission if you are certain there is no predicate available
A De Novo request needs to accomplish the following:
- 1. Prove that the device meets the standard for classification into class I or class II under section 513(a)(1) of the FD&C Act. In other words: prove that general controls or general and special controls would provide reasonable assurance of the safety and efficacy of the device.
- 2. Communicate all of the probable risks to health and probable benefits of the device, explain the measures needed to mitigate all probable risks, and explain how device safety and efficacy can be assured through the application of general controls or general and special controls.
You can read more about the De Novo pathway here. The team at Kapstone is available to help you figure out if you qualify for this option.
What does FDA approved mean?
Required for: All Class III devices
Class III devices carry the most risk for their end users and therefore require the most oversight from the FDA. The FDA “approves” Class III devices through a process known as premarket approval, or PMA. The purpose of a PMA application is to prove that your device is safe for its intended users and performs its intended function.
FDA approval can only be granted through the PMA application process. If a device has not been through this process, it should not be referred to or marketed as “FDA approved.”
Some Class II devices will also need to go through the PMA application process. Class II devices that can be proven to be substantially equivalent to an approved device (known as the “predicate”) can pursue FDA clearance through 510(k) premarket notification, but those without a predicate will need to follow the PMA process or submit a De Novo request if they qualify.
For more information on determining substantial equivalence and the 510(k) premarket notification process, check out this blog or get in touch with a Kapstone regulatory expert.
Connect with Medical Device Consultants
The team at Kapstone can help you classify your device and pursue FDA registration, clearance, or approval. Please do not hesitate to get in touch.