FDA approval and FDA registration are often confused, particularly when it comes to wellness devices and other machines used to deliver a specific type of therapy or health intervention. Although the two terms are often used interchangeably, they are actually quite different, and represent two different functions of the Food and Drug Administration of the U.S. What is the difference between the two? First, a glance at the individual types of FDA intervention is required. First up: FDA approval.
What Is FDA Approval?
The term “FDA approved” is often given a great deal of weight, but perhaps should not be given quite the intense degree of import that it is awarded. FDA approval is given to a product, practice, or device when there is enough evidence that has been compiled to suggest that the item in question accomplishes the goal identified by the FDA approval request. An MRI machine, for instance, is approved for use as a medical imaging device. Medications usually receive FDA approval only after several research studies have demonstrated the medication’s efficacy in its target area. FDA approval is the baseline for many people’s trust in medical, beauty, and wellness products and technologies, though there are plenty of additional certifications and verifications of an item or procedure’s efficacy.
What is FDA Registration?
While FDA approval suggests that something does what it claims to do, FDA registration means that the object, technology, or procedure is on the radar of the FDA, and that it has passed the basic requirements set forth by the FDA for use and distribution in the United States. FDA registration is typically ideal for wellness devices, like PEMF machines, because it means that the device in question has followed the rules set forth by the FDA in order to safely be distributed in the United States.
FDA registration is different from FDA approval, in that it is literally only a process of registering a product and its category, and does not require proof of efficacy. A device might be registered, for instance, as a wellness product designed to clean beneath your nails, but merely has to prove that it has been manufactured using safe practices and materials, and does not have to present the FDA with a study or body of research identifying its ability to actually clean beneath the nails.
Which Is Better for PEMF: FDA Approval or FDA Registration?
Seeking FDA approval for PEMF devices is not likely to be possible, and FDA registration usually will suffice. This is because FDA approval is granted specifically to certain types of medical devices with a medical designation. PEMF devices were given a different designation—a designation that identifies PEMF machines as “wellness” devices—and do not qualify for the FDA approval that is so often claimed by PEMF companies skewing data to sell machines.
Although it may be tempting to hold out for a device that has received FDA approval—one company, in particular, has suggested they are currently seeking FDA approval for their specific devices—FDA approval is decidedly unnecessary for PEMF machines and its corresponding therapy techniques. This is because PEMF therapy has already received FDA approval, and is known to be a safe and effective form of treatment for several ailments, regardless of the exact machine being used. Provided that the machine comes from a reputable company, can verify its construction and components, and has a history of strong functioning among customers, it will perform the functions set forth by the therapy’s FDA approval.
FDA Approval and PEMF: Approval for Specific Uses
Many PEMF sites—reputable PEMF sites—are known for suggesting that PEMF therapy has received FDA approval. This is true, and also where it can get difficult to separate fact from fiction: PEMF therapy as a practice has received several FDA approvals for use, including use as a muscle stimulant, a treatment for depression, and a treatment for cervical fusion, but separate PEMF machines have not. When individual companies claim that their products have received FDA approval, it is technically correct; after all, the FDA has given approval for PEMF devices. It is not accurate, however, if they claim that the FDA has delivered approval for their particular product.
The approval for specific uses with PEMF machines does not necessarily mean that PEMF can only be utilized for those conditions; instead, it means that those specific conditions had a solid body of evidence supporting their use at the time of approval. Rather than focusing on approval for all conditions, such as pain, search PubMed and other public sources of research studies to determine how likely the treatment is to work for a specific condition. Plenty of research has suggested, for instance, that PEMF therapy is a solid source of treatment for arthritis and pain, in addition to other conditions and symptoms.
Selecting a PEMF Device
Although it may be tempting to select a machine that claims to have FDA registration, or avoid PEMF therapy until a machine has achieved FDA approval, doing so negates the presence of existing FDA approvals for PEMF therapy as a whole, and discredits a number of reputable, effective machines currently in use and distribution. Because PEMF therapy has already received FDA approval for use as a treatment for certain health issues, you would do well to find a reliable, trustworthy company that makes PEMF machines, rather than focusing effort or energy on finding FDA approved individual machines.
With that in mind, when selecting a PEMF device, one of the best rules of thumb to follow is searching for reviews: if people have genuinely enjoyed the product, or industry professionals have given it glowing reviews, it is highly likely to perform its job well. Rather than searching for an FDA approved PEMF machine, search for a PEMF machine that has been registered with the FDA, is made with quality materials, and has a solid history of success with customers and PEMF authorities, alike. Doing so will ensure that you are using a machine that offers a superlative PEMF experience.