This webinar, featuring in2being co-founder and managing director Gene Parunak, clarifies four common but often misunderstood designations used by the FDA in its regulatory process:
- FDA registered
- FDA cleared
- FDA granted
- FDA approved
Although the FDA created these labels as part of its oversight process for medical devices, they’re often co-opted by companies for marketing purposes, which leads to a great deal of confusion.
For example, “FDA approval” applies only to medical devices subject to the FDA’s Premarket Approval (PMA) process. However, there’s a good chance you’ve seen products advertised as “FDA Approved” that haven’t gone through the PMA process.
FDA registration: FDA registration is an annual legal requirement for companies in seven different categories, including manufacturers of food, drugs, and medical devices. In FDA usage, the term “FDA registered” does not indicate anything about a company’s products. Rather, it signifies that the company has fulfilled its yearly regulatory obligation by paying a fee and filing paperwork with the FDA.
The remaining three terms apply to three pathways created by the FDA for medical technology companies to bring new medical devices to market. If you’re a medical device manufacturer, your FDA medical device classification determines your path to market.
FDA clearance: Before you can market some Class I and most Class II medical devices, you must file a 510(k) with the FDA. The purpose of a 510(k) submission is to prove that your device is safe and effective by comparing it to a similar, legally marketed device—what the FDA calls a “predicate device.” If your 510(k) submission is approved, your product has earned FDA clearance, and you can legally market it.
FDA granted: Some medical devices are not subject to the Premarket Approval process but they can’t be introduced to the market via a 510(k) submission, because no suitable predicate device can be found. In such cases, manufacturers must file a De Novo classification request. An approved De Novo request is “FDA granted”; the device is given a Class I or Class II label. Once a De Novo request is granted, a manufacturer can legally market their new medical device.
FDA approval: The FDA reserves the Class III label for high-risk medical devices—they’re used to “support or sustain human life” or “present a potential, unreasonable risk of illness or injury.” Consequently, such devices are subject to the FDA’s most rigorous path to market, the Premarket Approval process. The label “FDA Approved” applies only when a PMA application is successful.
Beware of cavalier use of these FDA regulatory terms in marketing materials!
For more detailed coverage of this topic, watch MedTech Crossroads Episode 23, “FDA Registration, Listing, Clearance, Granting, Approval… Oh my!”in2being partners with medical technology companies to help them bring new medical devices to market. Contact us to learn more about our services.
Clearance, approval, registration. . . They’re often used interchangeably, but what do they really mean?
Companies boost their perceived market value by implying that FDA has “blessed” their device. Statements like “we’re working towards FDA approval” or “our device is FDA-approved” are common.
But, does FDA even “approve” devices?
The short answer is “yes,” but only the highest risk, most complex, and most costly devices to get to market are actually “approved.”
Sound confusing? Let’s break down the different types of “recognition” you can get from FDA.
FDA Registered: This means your company has registered with FDA and paid a fee. FDA knows that you are selling a device or a service and can come audit you. FDA registration and listing doesn’t imply any blessing or goodwill on the part of FDA. An “FDA registered” company may have sent FDA a registration fee, but they have not necessarily been audited by the agency. In the same way, an FDA registered manufacturer has not necessarily been inspected by FDA yet. Some manufacturers will be registered with FDA for food or drugs and not even currently building devices. When you see “FDA registered,” it’s just an invitation to dig deeper. “FDA registered” communicates no authenticity, validity, or FDA goodwill.
FDA Cleared: When used correctly, this term refers to FDA allowing a device to market through the 510(k) process based on substantial equivalence to a legally marketed predicate device. It doesn’t sound as glamorous as “FDA approved,” but “clearance” is a critical step on the path to market for many devices. A device that is truly “cleared” may not have FDA’s affirmative blessing, but it has certainly passed a basic level of scrutiny and the door is now open to market.
But many devices, especially health and wellness or even 510(k) exempt devices, erroneously claim that they are FDA “cleared.” Think about it. If the device never required a 510(k) clearance in the first place, the words “FDA cleared” are meaningless.
Here’s a device being sold at a major online retailer that claims to be both “class I” and “cleared.” Devices like this one, while subject to GMP (good manufacturing practices), do not require a 510(k) clearance. So adding words like “FDA cleared” to the marketing material may sound good, but they do not represent that FDA has taken any activity toward the device.
Granted: The term “granted” is used by FDA to describe a favorable outcome to a de novo classification request. This means that a company has successfully worked with FDA and that their device can be safely marketed through general controls or general controls and special controls without demonstration of substantial equivalence. On the path to market, a granted de novo request has roughly the same weight as a “cleared” 510(k) submission. Both mean that FDA has opened the door to the market.
FDA Approved: This term is reserved for the highest risk “Pre market approval” or PMA devices. It is only this small subset of devices, subject to incredible scrutiny, which actually earn the label “FDA approved.” Unfortunately, this is also perhaps the most abused term out there.
Here’s a hearing aid sold online. Most hearing aids are either class I or class II devices. There’s no reason to believe anyone got a PMA, but here’s a hearing aid marketed as “FDA-approved.”
We see “FDA approved” stamped everywhere these days, including on devices that have not even been registered with, let alone reviewed by, the agency.
All this to say, buyer beware.
Feel free to reach out to in2being for assistance with these terms, and if you’re developing a medical device, contact us to learn how in2being can be your medical device development partner. Additionally, see our video about FDA Medical Device Classifications.