The Food and Drug Administration is given a great deal of credence when it comes to the United States and products coming into the U.S. This is due, largely, to the organization’s reputation as a safe governing body and channel through which products are deemed safe, responsible, or effective. Although the precise nature and ruling scope of the FDA is less than is typically perceived, utilizing the FDA in your search for a PEMF device can prove useful, and can help you discern between purchasing a machine that has been approved through the proper channels, and a machine that has been distributed under the radar of United States regulations. First, a review of the different types of FDA of involvement is in order, to demonstrate the potential PEMF and FDA intersections.
What Is FDA Registration?
Many PEMF machines will have “FDA registered” placed on their marketing materials. For many, this is tantamount to an FDA approval, and makes the machine appear to be more legitimate or more thoroughly regulated. This is not necessarily the case, however, in that FDA registration does not require companies to submit proof of efficacy. Instead, FDA registration requires that the device in question be given a purpose, proof of safety, and evidence of appropriate use and distribution. FDA registration is common for wellness products, such as supplements, and involves a relatively simple process.
FDA registration is technically necessary to sell products in the United States, but there are ways to get around the process—and purchasing products without at least FDA registration can mean purchasing products that are potentially hazardous, and do not adhere to basic safety standards considered necessary by the United States. Workarounds can include registering a product as a U.S.-based company and making it elsewhere, or manufacturing it in the U.S., and selling it directly to customers. These workarounds can be utilized to save on manufacturing costs, or to avoid scrutiny, and PEMF devices without an FDA registration tag should typically be avoided.
What Is FDA Approval?
FDA approval differs from FDA registration in its depth. FDA approval means that a therapy, technology, or item has been presented along with a body of evidence supporting its use. PEMF therapy, for instance, has received FDA approval for 5 different uses, including (but not limited to) depression, cervical fusion, and muscle stimulation. FDA approval of these uses means that PEMF therapy has presented enough bodies of evidence to support its use as a therapeutic intervention in these ailments, the FDA subsequently approved the use of the machines for this purpose, and marketing materials are legally allowed to use these claims in marketing campaigns.
FDA approval can be used for individual companies or products, but may be more common with general practices or therapies. This means, for instance, that PEMF therapy has been approved for use in treating depression, but the FDA has not stipulated a particular brand, company, or patented technology for use in treating depression. For this reason, virtually any brand of PEMF machine can be used in the treatment of FDA approved conditions in clinical and healthcare settings, and selecting the best brand or machine is based on personal preferences, individual needs, or brand offerings, rather than FDA approval.
FDA Approval: Why Approval Is Not Attached to Devices
Although it may seem unwise to not seek FDA approval for a specific PEMF device, the move of companies to seek registration instead of approval is an intentional one: to receive FDA approval of a PEMF device, that device has to be tied to a specific ailment treated by PEMF therapy. Seeking approval in this way would limit the application of that particular device, and companies would not be able to release their machines as multi-purpose, multi-functional devices. In short, the scope of PEMF therapy would be greatly weakened if FDA approval was granted to individual machines and companies. FDA approval for the therapy overall demonstrates the efficacy of the therapy itself, while FDA registration for individual brands and machines allows machines to be distributed for a greater range of illnesses and conditions. Understanding the purpose of seeking FDA registration instead of FDA approval can alleviate fears or concerns about the lack of an “FDA approved” tag for a PEMF machine.
Is FDA Approval Better Than FDA Registration?
In some cases, FDA approval is preferable to FDA registration, because FDA approval requires a body of evidence to support a machine or technology’s use. In cases involving wellness devices like PEMF therapy, however, FDA approval is usually unnecessary. This is because FDA approval for PEMF therapy is not dependent upon a specific brand or type of machine, but is instead based on the therapy as a whole, just as a specific brand of vitamin is not the sole delivery source for that vitamin.
Choosing a PEMF Machine: Navigating the FDA
Navigating the ins and outs of FDA involvement in therapy devices can be difficult. Some machines will claim that they are FDA approved, while others correctly cite FDA registration. In both cases, it is the type of therapy, generally, that has been evaluated and approved by the FDA, rather than a specific PEMF therapy machine or company. Selecting a PEMF machine, then, is best suited to looking at the specifics of the machine itself—its therapy inclusion offerings, its intensity availability, waveform inclusion, and frequency availability—because the settings of the machine are the components actually controlling the efficacy of the machine.
Using a machine that has been registered with the FDA means that you are using a machine that has gone through the proper channels, and is being distributed, built, or imported into the United States legally, with some degree of oversight. Purchasing items that do not have an FDA registration number or certificate means that you are purchasing an item that does not have a paper trail, and is not held accountable according to U.S. licensing should any issues regarding the machine arise. Although it is not necessary or even possible to purchase a PEMF machine that has received FDA approval, it is ideal to purchase a machine that has been registered with the FDA.