Understanding the Difference Between FDA Approval and FDA Clearance

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.
1. 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 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.
2. 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, 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.
3. 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.
4. 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.
Link to FDA registration and listing database:
www.accessdata.fda.gov/script...
Related topics:
De Novo Submission
510(k)
PMA
Registration and Listing
Not Legal Advice
www.in2being.com

[@andybvt]

here are 2 stories 1) Typical client payout for product liability is 8% 2) not a single lawyer would ever stand up in congress and try to stop any of these products being produced because these injuries produces millions of dollars for this industry every year.

[@williamhui6195]

We found our N95 respirator can be registered as FDA product code MSH in FDA database with no 510(k) is needed. Once we got the establishment number issued by FDA, we can only use FDA registered for our N95 respirator. However, why we cannot declare our N95 respirators as FDA cleared? How should we do if we want to be FDA cleared eventually?

[@Melinna48]

Are there legal limitations on marketing an FDA cleared device? For example, if the device is approved for treating specific diagnoses, what happens if the device is used for treating more diagnoses?

[@medtechcrossroads]

Melinna, good questions. Feel free to reach out through our website contact form at in2being.com for more information, but in short, the intended use of the device and the indications for use as cleared by FDA determine what how the device can be legally marketed. While doctors and patients may decide to use a device "off-label", the marketing company's statements are limited to what claims the device is actually cleared for.

[@greenstar3411]

Emergency Auth?

[@jackmomesso]

FDA help American company and push down other , is it normal ???.