The Difference Between FDA-Cleared and FDA-Approved Medical Devices - Is the Biomat FDA-approved?

What’s the Difference Between FDA Cleared & Approved Medical Devices?

The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of medical devices before they are marketed and sold in the United States. The terms "FDA-cleared" and "FDA-approved" are often used interchangeably, but they actually refer to different processes that medical devices undergo to gain FDA authorization. In this blog post, we will explore the differences between FDA-cleared and FDA-approved medical devices, and specifically examine the case of the Richway Biomat, which is an FDA-approved medical device. We will also compare it to its competitors, such as Healthy Wave, Ereada, Medicrystal, and HealthyLine.

The FDA is responsible for regulating the sale and monitoring the safety of all medical devices in the U.S. Before a medical device can be sold or marketed, it must be approved or cleared by the FDA.

To obtain FDA-clearance, the device manufacturer must submit a 510(k) application to the FDA, along with evidence showing that the new device is "substantially equivalent" to a device that is already on the market. The substantial equivalence can be demonstrated by showing that the new device has the same intended use and similar technological specifications as the predicate device. This process is relatively quick, with the FDA making its determination within 90 days of submission.

The process that a medical device must go through to get FDA-approved for actual health issues is rigorous and involves multiple stages. First, the device manufacturer must conduct extensive laboratory testing and preclinical studies to assess its safety and effectiveness. These findings are then submitted in a premarket notification, known as a 510(k) or a premarket approval (PMA) application, depending on the device's classification. The FDA reviews the application, evaluating the device's design, materials, manufacturing processes, and proposed labeling. If the application is deemed complete, the FDA conducts a thorough review, including clinical data from human trials, to determine if the device meets the necessary standards for safety and efficacy. The FDA may also inspect the manufacturing facilities. Finally, if the device is approved, it can be marketed and sold for its intended use, with post-market surveillance and monitoring to ensure ongoing compliance with regulations. This rigorous process ensures that medical devices are safe and effective for addressing health issues. The process is long and costly.

Is the Richway Biomat FDA-Approved?

Now let's focus on the Richway Biomat, which is an FDA-approved Class II medical device. The Richway Biomat is a infrared therapy device that combines far-infrared rays, negative ions, and amethyst crystals to provide benefits such as pain relief, improved circulation, and relaxation.  To obtain approval, Richway submitted a 510(k) application and then provide the FDA with complete information about the design of the Biomat, the manufacturing process and the manufacturer itself (Richway owns its own manufacturing facility under its partner, Fuji Bio, Inc.), the labeling of the Biomat, and extensive clinical human trial data. The FDA reviewed Richway's information and put them and the Biomat through a multi-stage, lengthy and expensive process that culminated with FDA-approval.

What Exactly is the Biomat FDA-Approved For?

The Biomat has been approved by the USFDA for temporary relief of minor muscle pain, joint pain, stiffness, arthritis-related pain, muscle spasms, sprains, strains, muscular back pain, muscle relaxation, and temporary increase of local circulation.

Are the Infrared Therapy Mat Knockoffs FDA-Approved?

When comparing the Richway Biomat to its competitors, such as Healthy Wave, Medicrystal, Ereada, and HealthyLine, it is important to consider the FDA approval status. While other companies may offer infrared therapy mats with features they copied from the Biomat, the FDA approval of the Richway Biomat provides an added level of assurance regarding its safety and effectiveness for the indicated uses. It signifies that the device has undergone stringent evaluation and met the FDA's standards for approval. It is important to remember, the Biomat is the ONLY infrared therapy mat FDA-Approved for actual health issues.

Some of the knockoff companies claim to be FDA-approved and when you look deeper, what they use to back up that claim is that they say the factory in China where their mats are made is FDA-approved.  Even if this is true, and the Chinese FDA actually approves facilities instead of actual products, this does not mean the United States FDA has approved their product like it has the Richway Biomat.  While it may inspect properties as part of the approval process for products, the USFDA does not approve facilities, much less ones in other countries.

On Medicrystal's site, it states that their products come from a "FDA-registered manufacturer in China".  They may have submitted a 510(k) notification with the FDA and may have been cleared, but their mats are not approved by the USFDA.  Because the Biomat was approved before any other infrared therapy mat was made, all those that follow can be cleared.  So any knockoff that gets clearance owes that clearance to Richway. 

There is no such thing as "FDA-registered".  A device has either been cleared or approved but there is no designation, as far as the FDA is concerned, for "registered".  Companies use this to dodge the fact that their products have not undergone the rigorous approval process, usually because they know their products will not hold up to the standards required for approval.  Coincidentally, HealthyLine's products are made in the same "FDA-registered" factory in China. 

Ereada also claims its factory is "FDA-registered".  It just sounds better than "FDA-cleared". Healthy Wave, at least, is honest about their clearance status.

In conclusion, the FDA clearance and approval processes distinguish between medical devices that are substantially equivalent to already approved devices and those that require rigorous clinical studies to demonstrate their safety and efficacy. The Richway Biomat stands out as an FDA-approved medical device, specifically indicated for the relief of minor muscle and joint pain, arthritis, muscle spasms, relaxation of muscles, and temporary increase in local circulation. When comparing it to its competitors, the FDA approval status of the Richway Biomat highlights its adherence to strict regulatory standards versus knockoffs that simply got FDA clearance based on the approval Richway obtained before them.  This is another reason why those knockoffs claim their products are "comparable to the Biomat", likening their products to an approved device helps them sell their mats.  

Don't settle for products that have not been proven to do anything.  The Richway Biomat is, and always will be, the gold standard of infrared therapy mats.