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- 16 Apr 2021, 11:35
#4730
There are different types of "recognition" you can get from US FDA after your registration. FDA Approved, FDA Cleared and FDA Granted recognition are provided by FDA. Individual types are explained below for your understanding.
Different types of US FDA Registration (or) Recognition
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 to ensure the availability and etc. 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.
FDA 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.
Different types of US FDA Registration (or) Recognition
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 to ensure the availability and etc. 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.
FDA 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.
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