What is FDA Approval, and How Does It Apply to PEMF Devices?

Quite often, manufacturers boast that their PEMF devices are FDA registered and make this as an important selling point. In fact, there are two services that the FDA provides when it comes to PEMF devices – FDA registration and FDA approval. For common purchasers, it is easy to confuse PEMF registered and PEMF approved devices. So, manufacturers make use of this and hope that the customers will assume FDA registration as a form of reassurance.

However, FDA registration is different from FDA approval. If a PEMF device is FDA registered, it only means that the FDA is aware of the fact that the item is being imported into the USA. Actually, all medical devices imported into the USA need to be FDA registered. So, it is fake marketing that many manufacturers claim that their PEMF devices with FDA registration are better than others. FDA registration is by no means a guarantee of safety, efficiency, or quality.

Certainly, there are some FDA – approved PEMF devices in the market. FDA approval can be earned by proving that a PEMF device can be used to treat a specific health condition successfully. In addition, this device needs to undergo a rigorous testing process to prove that its benefits far outweigh its risks. However, FDA approval is not a bulletproof guarantee of quality. The FDA approves many drugs and medical devices that subsequently have to be withdrawn for safety reasons. That being said, with these FDA-approved PEMF devices, we can make sure that the FDA does approve the therapeutic use of pulsed electromagnetic fields for many health conditions. There are a growing list that have been approved.

In 1979, the FDA approved PEMF Therapy for the healing of non-union fractures.

In 1998, the FDA approved PEMF Therapy for urinary incontinence and muscle stimulation.

In 2004, the FDA approved PEMF Therapy for cervical fusion patients at high-risk of non-fusion.

In 2006, the FDA approved PEMF Therapy for treatment of depression and anxiety.

In 2011, the FDA approved PEMF Therapy for treatment of brain cancer.

The medical community is becoming increasingly aware of the healing powers of PEMF Therapy. On October 13th, 2015, the FDA acknowledged the safety and effectiveness of PEMF therapy by reclassifying PEMF devices from Class 3 category to Class 2. It means that PEMF devices are safe for private individual use.

Furthermore, most manufacturers do not want to earn FDA approval mainly for two reasons. On the one hand, it is very expensive to seek FDA approval. On the other hand, a PEMF device approved by the FDA needs to be condition-specific. However, PEMF therapy can help with a wide range of health conditions, so many manufacturers and patients believe that FDA approval means a limitation to their benefits.