FDA Cleared vs. FDA Approved: What’s the Difference?

Many people have asked us why we’re just FDA Cleared, and what the different between Cleared and Approved is. The difference actually has nothing to do with quality, nor is FDA Approved better than FDA Cleared. Here’s how it works:

The FDA separates the items under its purview into three groups, which it calls Class I, Class II and Class III. An item’s product type determines which Class something is, and which Class something is determines whether it is Approved, Cleared, or Registered.

 TermExamplesRequirement
Class IRegisteredToothbrushes, elastic bandages, enema kits93% are exempt from pre-market review.
Class IIClearedWheelchairs, some pregnancy tests, Aulisa’s Guardian AngelFDA review through premarket notification (510(k)
Class IIIApprovedImplantable pacemakers, breast implants. Medicines also require FDA “Approved”.FDA review through premarket approval (PMA) or humanitarian device exemption (HDE)

That means your toothbrush is FDA Registered because it is the type of classification given to toothbrushes by the FDA, not because you have a sub-standard toothbrush. Similarly, our Guardian AngelTM Rx* line of products is FDA Cleared because that’s what our type of product is given by the FDA.

Source: https://www.fda.gov/medical-devices/resources-you-medical-devices/consumers-medical-devices

 

*Guardian AngelTM for in-home use applies the same FDA Cleared technology used in our Rx line of products.

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