Is BEMER therapy FDA approved?
BEMER therapy is US FDA approved, but it depends on how a person interprets the term approved. To be precise, BREMER devices are registered with the US FDA, which does not essentially mean approval of therapy by the FDA.
It is a valid question but complex. One cannot understand the stand of the FDA regarding BEMER therapy without understanding a few basic things about the policies of the US FDA.
US FDA has registered many BEMER devices
It is vital to understand that US FDA does not essentially approve a therapy. It is because the US FDA is not an organization involved in medical research; instead, it is a regulatory agency. Therefore, all the US FDA does is register or approve devices based on the safety and efficacy data. So, yes, there are many BEMER devices registered by the US FDA, but BEMER therapy is not essentially approved by it.
It means that every BEMER device should get individual registration of approval. There is no such thing as approval for all the devices in a particular category or approval of a specific therapeutic approach.
However, registration of BEMER therapy devices by the US FDA does say a lot about it. First and foremost, the FDA ensures that any device it registers is proven safe. Additionally, it must be clinically proven to work.
When applying for US FDA registration, one cannot make just any kind of wild claims. US FDA only believes in clinical evidence proven by documents. Therefore, it accepts dossiers prepared in a specific format.
Not only that, US FDA approval or registration means that the device would be considerably monitored for its safety and efficacy. For example, US FDA thinks that even if any device is safe, it cannot be approved if it does not help as intended.
Registration of BEMER device by US FDA means higher safety and efficacy
So, US FDA registration confirms that any device is safe, and it also works. However, indirectly it also says that US FDA approves that therapeutic approach.
This is true not just for devices but also for anything registered by the US FDA. Just take an example of hypertension therapy. US FDA does not approve specific therapeutic approaches to hypertension, but it registers individual drugs. However, registration of specific drugs may indirectly indicate the organization’s approval of that therapeutic approach.
Further, it is vital to understand that US FDA registration of the first device in a class differs from the consequent registration of similar devices.
It means that registration or approval of the first device is quite complicated, as the manufacturer needs to provide extensive data on safety and efficacy.
However, subsequent registration of similar kinds of devices is simpler, quite like generic drugs. This is because the US FDA already knows that certain types of the device would work, and thus a need to provide minimal clinical data.
Thus, once any device is registered with the US FDA, theoretically, it has also approved that therapeutic or device class.
Since there are multiple BEMER therapy devices registered by the US FDA, it would be correct to say that it is a US FDA-approved therapy. It means that if any manufacturer wants to register their device with the regulatory agency, things would be relatively simpler. It is because one only needs to prove to the agency that their device is equivalent or similar to already registered BEMER devices.
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To conclude, US FDA registers devices after extensive clinical trials. However, once the device is registered with US FDA, it would be correct to say that give therapeutic approach is approved by the agency.
Hence, yes, there are many BEMER devices registered by the US FDA, and it is an approved therapeutic approach that is proven to work in multiple high-quality clinical trials.