What does FDA cleared even mean?
I see so many products claiming FDA cleared, FDA registered, FDA approved?….it’s maddening!!
Trust me, we understand the confusion. The jargon and terminology for anybody who is not familiar with the process is very confusing.
Technically every medical device/product is supposed to “register” with the FDA, so advertising FDA registered is frowned upon by the FDA because it implies something more than what you are legally bound to do anyhow.
But some still do it…even people who used to represent us did this against my wishes.
FDA approved is reserved for medical devices/products that are life threatening in nature.
This is one of the highest forms of FDA certifications and requires significant testing, studies and monitoring before the FDA will allow a product/device to claim FDA approved status and subsequently be marketed in the USA.
FDA cleared is for products/devices that are non-life threatening and in a lower classification than FDA approved products.
FDA cleared is also not common.
A lot of products claim to be FDA cleared because they filed what is called a 510(k) application through the FDA. A successful 510(k) application results in a finding of being cleared to market by the FDA because of “substantial equivalence” to another product already marketed in the USA.
However, if you are a similar product performing a similar function to something already in the marketplace, a 510(k) application through the FDA is not necessary.
You only need to file a letter of “substantial equivalence” or PMA which means Pre-Market Approval.
But a lot of products that are “substantially equivalent” to something already in the marketplace, file a unnecessary 510(k) application to the FDA to achieve the status of being “cleared” through this application so that they can receive a 510(k)# and then claim to be “FDA cleared” when marketing their product.
Where it gets doubly confusing is….the same terminology is used in both scenarios.
A new, “substantially equivalent” or PMA product does not require a 510(k) review.
However, as we stated above, the findings of a proper 510(k) review by the FDA is that the reviewed product is “substantially equivalent” to another product(predicate device) already marketed in the USA.
The true intent/purpose of a 510(k) review is supposed to be reserved for products that are the 1st of their type/design that does something similar to another product(predicate) but in a manner that is different and introduces a brand new way to do the same thing.
Lo-Bak TRAX is truly “FDA cleared”, because as the FDA informed us during a formal 513(g) inquiry that, Lo-Bak TRAX, “introduces a different fundamental scientific technology to Non-Powered Orthopedic Traction”.
Therefore, it was determined that Lo-Bak TRAX had to file a formal 510(k) application through the FDA and be properly reviewed prior to it being allowed to be marketed in the USA. A PMA was not possible because Lo-Bak TRAX did something similar to an existing device, but the way Lo-Bak TRAX did it was Brand New & never seen before.
Lo-Bak TRAX submitted the 510(k) application and it was cleared by the FDA on August 2, 2011. Lo-Bak TRAX was given the “clearance” to be marketed in the USA and was assigned the FDA 510(k) cleared # K110858.
You can review Lo-Bak TRAX’s status on the FDA website by searching it’s name or FDA clearance # K110858.
The FDA does stop products from advertising improperly as “FDA cleared” but they first need to be aware of this. Because of the confusing definitions, the public is very rarely aware if a product is truly “FDA cleared” or just using the term as a marketing ploy. Subsequently skepticism arises and people are unsure of product/device FDA claims.
This is unfortunate for products like Lo-Bak TRAX that properly followed the FDA protocol and earned the title and status of being "FDA cleared”.
Please know that Lo-Bak TRAX has truly been formally reviewed by the FDA under the 510(k) process and was found substantially equivalent to it’s predicate device and assigned a FDA cleared number of #K110858.