The Food and Drug Administration is often relied upon as a source of comfort when seeking new products and trying out new therapies.
The term “FDA” used in conjunction with an item often brings an air of legitimacy to a product, and helps consumers feel as though they are selecting an item that has passed rigorous inspection and testing, to make sure it is safe and effective.
Although the FDA is important in evaluating incoming products and therapies, there are different designations associated with the Food and Drug Administration, the two most common being FDA approval, and FDA registration.
The differences between the two are significant, however, and should not be ignored.
What Is the FDA Responsible For? Approval and Registration
The Food and Drug Administration is a government-supported entity that was developed to ensure public health.
The FDA is responsible for making sure that all cosmetics, food items, medical items, and drugs are safe for the standard consumer, and will not present a danger to those who use it.
Applying for approval through the FDA requires proving that the claims you are making are legitimate and backed by research, and places you at risk of losing your approval or greater penalties if you falsify your claims or exaggerate your products’ abilities.
There is a different between approval and registration, though, and the difference between the two is substantial.
FDA registration is a relatively straightforward process: in order for a product to be imported to the United States, it must be identified and registered with the FDA.
FDA registration is essentially designed to make sure that government entities know of any and all medical equipment entering into the country, should any issues arise with that equipment.
The registration process does not require intense evaluation or follow up, and should not be viewed as a reliable indicator of a product’s quality or efficacy.
The registration process provides a great way for the FDA to keep tabs on all incoming medical equipment and other items, but does not claim to offer any real guarantee regarding the safety or value of the product in question.
The process involved in seeking FDA approval is different from that of registration.
Before a medical item is brought in from another country and placed up for sale, it must undergo the registration process.
Before a medical item can be sold with the FDA stamp of approval, it must be evaluated and vetted for efficacy and honesty in its claims.
Although FDA approval can be removed, if an item is proven to be unsafe, or increasing bodies of evidence suggest it does not work for its intended purpose, an FDA stamp of approval can be a more reliable indicator of a product’s reliability.
The FDA and PEMF Therapy: Why Approval Is Important
Although FDA registration is not a bad thing, it does not guarantee rigorous testing or a trustworthy acknowledgement that a product is safe or effective.
FDA approval, conversely, is only given after an item has proven its use, and claims have been evaluated.
Making claims without FDA approval will likely not be penalized, but making claims on an FDA-approved product that are not supported can result in a fine, or a removal of a product from shelves and online retailers.
That being said, there are varying levels of approval awarded by the FDA, based on the type of product being approved, and the potential drawbacks of the item.
Items that have an extremely low risk of issues are labeled as Class 1 items, and include simple personal hygiene items such as dental floss and toothbrushes.
Items with more significant risks are identified as Class 2 items, and include sexual and reproductive health items such as condoms.
Class 3 items are items that come with a serious risk, and can include items such as pacemakers.
A Class 1 certification is typically going to be an FDA registration.
Because registration does not require follow up or in-depth evaluation, items that fall into Class 1 are not considered items designed for medical treatment.
PEMF therapy machines that are given only a Class 1 certification, then, are not machines intended for use as actual therapy interventions, and should not be regarded as such.
A Class 2 certification is synonymous to the FDA term “FDA Cleared.”
If something is FDA Cleared, it is not considered particularly dangerous, and is not regarded as a viable source of therapy or health support.
For this reason, both Class 1 and Class 2 items are marketed as “health promoting,” rather than identifying a specific disorder, condition, or need the item in question might be able to heal or aid.
A Class 3 certification is the most intensive of the 3 classes, and is typically reserved for items that claim to provide some form of medical treatment.
PEMF therapy machines will fall under this class (FDA Approved), provided that all of the proper channels are gone through.
PEMF Therapy Machines, Therapy Delivery, and the FDA
PEMF therapy machines fall under Class C, because they are used to deliver therapy.
Although registration under Class C requires evidence to support claims, some companies are able to get out of this requirement by simply registering their items with the FDA, rather than petitioning for FDA approval.
This is one of the most important measures to examine when choosing a PEMF machine.
An FDA registered PEMF therapy machine has not been properly vetted to make sure it is actually capable of delivering the therapy it claims to be able to deliver.
PEMF is an important therapy to aid in wound healing, pain relief, post-surgical recovery, mental health, and even range of motion, all of which can significantly contribute to overall health and well being.
When seeking out a PEMF therapy, there are several options: seeking a PEMF professional, or self-administering PEMF therapy according to manufacturer’s specifications.
Going the second route can be perfectly safe and effective, provided that the machine itself and the manufacturer’s instructions follow the safety precautions and usage guidelines set forth by research studies and long-term evaluations.
PEMF therapy is a safe and effective form of therapy—safety and efficacy that is more effectively delivered by a machine approved by the FDA.