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What does “FDA Cleared” Mean?
Vidcast: https://youtu.be/NZAh4xw4Cl4
I recently saw an ad for a portable EKG device called the KardiaMobile 6L. It’s a clever little device that permits you to record a 6 lead EKG at home. What caught my eye was the term FDA-cleared on the ad. So I checked on the FDA’s website to find out just what that means.
The first step in the process of legal marketing of a medical device in the US is registration with the FDA. If an FDA Registered medical device is substantially similar to a medical device previously registered, proven by rigorous testing to safe and effective, and approved by the FDA, it becomes FDA Cleared for marketing. A device that is only FDA Cleared has itself not been subjected to the rigorous testing necessary to be labeled FDA-Approved. If a device is not obviously similar to one approved, the FDA can still grant it an administrative clearance for marketing, the the device will be deemed FDA Granted. Only devices that have undergone controlled testing and proven beyond a doubt safe and effective are granted the designation FDA Approved.
Sadly, many consumers assume that the two labels, FDA-cleared and FDA-approved mean the same thing. UNTRUE. There have been a number of cases where devices have been FDA-cleared based on their similarity to devices that have subsequently been recalled and removed from the market due to patient injuries. In some cases, unethical manufacturers or importers just slap an FDA registerered, cleared, granted, or even approved label on a product without any justification.
So there is nothing wrong with the KardiaMobile device. Just know, though, that the FDA has not verified that this so-called cleared device or any other merely cleared or granted device itself is proven safe and effective. It is merely rubber stamped as cleared. Buyer beware.
https://www.fda.gov/media/72646/download
https://www.rcclaw.com/understanding-the-difference-between-fda-approved-and-fda-cleared-is-crucial-to-defective-medical-device-litigation/
https://store.kardia.com/products/kardiamobile6l
#fdacleared #fdaapproved #recalls
View all episodes
By Howard G. Smith MD, AM
Vidcast: https://youtu.be/NZAh4xw4Cl4
I recently saw an ad for a portable EKG device called the KardiaMobile 6L. It’s a clever little device that permits you to record a 6 lead EKG at home. What caught my eye was the term FDA-cleared on the ad. So I checked on the FDA’s website to find out just what that means.
The first step in the process of legal marketing of a medical device in the US is registration with the FDA. If an FDA Registered medical device is substantially similar to a medical device previously registered, proven by rigorous testing to safe and effective, and approved by the FDA, it becomes FDA Cleared for marketing. A device that is only FDA Cleared has itself not been subjected to the rigorous testing necessary to be labeled FDA-Approved. If a device is not obviously similar to one approved, the FDA can still grant it an administrative clearance for marketing, the the device will be deemed FDA Granted. Only devices that have undergone controlled testing and proven beyond a doubt safe and effective are granted the designation FDA Approved.
Sadly, many consumers assume that the two labels, FDA-cleared and FDA-approved mean the same thing. UNTRUE. There have been a number of cases where devices have been FDA-cleared based on their similarity to devices that have subsequently been recalled and removed from the market due to patient injuries. In some cases, unethical manufacturers or importers just slap an FDA registerered, cleared, granted, or even approved label on a product without any justification.
So there is nothing wrong with the KardiaMobile device. Just know, though, that the FDA has not verified that this so-called cleared device or any other merely cleared or granted device itself is proven safe and effective. It is merely rubber stamped as cleared. Buyer beware.
https://www.fda.gov/media/72646/download
https://www.rcclaw.com/understanding-the-difference-between-fda-approved-and-fda-cleared-is-crucial-to-defective-medical-device-litigation/
https://store.kardia.com/products/kardiamobile6l
#fdacleared #fdaapproved #recalls