FDA-Cleared Versus FDA-Approved?

June 16, 2021 FDA-Cleared Versus FDA-Approved?

If you have ever wondered about the difference between FDA-Cleared versus FDA-Approved LED Light Therapy devices, then read on for a full explanation.

The FDA regulates all medical claims made by device manufacturers regarding their products. The Agency uses two different processes based on comparative risk for reviewing medical claims before manufacturers are permitted to make those claims commercially.


The 510(k) Process

 The 510 (k) process is intended to review devices that are better understood by the Agency and/or potentially less hazardous to patients, like Celluma red light therapy devices. This process is most often used to review Class II devices. This is a less burdensome review process and if the Agency concludes that the manufacture has demonstrated the device is substantially equivalent to a legally marketed device, the device is “cleared” for commercialization. A device being “cleared” is not a reflection on the efficacy of the device, only an indication of the comparative risk in use.


The Pre-Market Approval (PMA) Process

 The Pre-Market Approval (PMA) process is intended for devices not as well known to the Agency and that pose a greater risk to the patient, like implantable devices. An example would be a heart stint. These types of products are considered Class III devices. A PMA is a more burdensome process and if the Agency concludes the manufacturer’s claims are supported using this process, the device is “approved” for commercialization. As a particular Class III device becomes better known to the FDA, it may be re-classified as a Class II device, meaning any subsequent review of such devices by the Agency will be done using the 510(k) process. Again, a PMA “approval” does not denote the relative efficacy of a device, only the comparative risk of the device in use.

 That said, a device “clearance” is not somehow a subordinated “rating” by the FDA in comparison to an “approval.” It is just the favorable conclusion of a different review processes used by the Agency, depending on how common and how risky is the device getting reviewed. 

 Given that LED Light Therapy is a well-known modality of treatment to the FDA, and possesses little to no risk to the user, such devices are subject to 510(k) review and are “cleared” for sale by the FDA.   That being the case, a product that is advertised as FDA APPROVED LED LIGHT TREATMENT is an incorrect use of the Agency’s nomenclature and a likely indication of false advertising. FDA APPROVED LED LIGHT TREATMENT is not a “thing” because LED devices are not reviewed by the FDA using the PMA process. 

 If you see an advertisement for an FDA APPROVED LED LIGHT TREATMENT or a manufacture tells you they sell FDA APPROVED LED LIGHT TREATMENT, they either don’t know what they are talking about, they are trying to mislead you, or both. LED Light Therapy devices are cleared by the FDA, they are not approved. So buyer beware . . .  something purported to be an FDA APPROVED LED LIGHT TREATMENT has likely not been subject to any FDA review, because the Agency is very specific as to how reviewed devices are to be advertised.

Stephen Freeland