PEMF & FDA

In the USA, NO PEMF machines have been, clearedapproved or certified for use for general purpose health applications by the USA Food and Drug Administration. Some devices are listed on the FDA website as massage or biofeedback devices but NO one is cleared, approved or certified for PEMF pain relief.

 

There are companies who mislead customers and tell them that their device has been FDA approved and some of companies simply lie on their website. We recommend you to read the following explanations to understand more about FDA regulation for PEMF devices.

 

  • Classification
     

  • Clearance 510(k)
     

  • Approval [PMA or Premarket Approval]
     

  • Listing
     

  • GMP [Good Manufacturing Practice]


Classification of Medical Devices in the USA by the FDA

 

The FDA categorizes medical devices into one of three classes: Class I, II, or III based on risks and regulatory controls, to provide the safety and effectiveness. Class I devices generally pose the lowest risk and Class III devices pose the highest risk.

 

Class I are for low risk devices and are therefore subject to the least regulatory controls. For example, dental floss is classified as a Class I medical device.

 

Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II medical devices. 

 

Class III devices are the highest risk [life threatening] devices and are subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are allowed to be marketed. For example, replacement heart valves are classified as Class III devices. 


Clearance for Medical Devices by the FDA

 

Before a medical device can be marketed in the USA a marketing application must be submitted to the FDA and clearance obtained.

 

Most Class I devices and some Class II devices are exempt from the requirement for submission of a marketing application. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled.

 

Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A pre-market notification, referred to as a 510(k), must be submitted to FDA for clearance in order to demonstrate that the device is safe and effective and substantially equivalent to a legally marketed device for which no pre-market approval is required.

 

510(k) Exempt medical devices: Medical devices that do not require FDA review before the devices are marketed are considered "510(k) exempt." These medical devices are mostly low-risk, Class I devices and some Class II devices that do not to require a 510(k) to provide a reasonable assurance of safety and effectiveness. They are not exempt from certain general controls, like suitable for intended use, properly labeled and manufactured under a quality system.

 

Approval of Medical Devices in the USA

 

Pre-market Approval is the most stringent type of device marketing application required by FDA. A pre-market approval application is submitted to FDA to request clearance to market, or to continue marketing of a Class III medical device.

Approved medical devices are those devices for which FDA has approved a PMA application prior to marketing. This approval process is generally reserved for high-risk medical devices and involves a much more rigorous pre-market review than the 510(k) pathway.

For use of PEMF technology this PMA approval process is required, which may take around 5 years and will possibly cost millions of dollars, without the knowledge if by the end of this process, the device will be approved by the FDA or not. Even in case such an approval will be obtained the application is usually limited only to one application. No manufacturer of PEMF machines will opt for this unsure and very expensive process.


Good Manufacturing Practice for Medical Devices

 

Good Manufacturing Practice are the requirements set forth in the Quality System regulation and require that manufacturers have a quality system for the design, manufacture, packaging, labeling, storage and servicing of medical devices intended for distribution in the USA and the rest of the world.


Listing of Medical Devices by the FDA in the USA

 

A medical device is FDA listed if the company manufacturing or distributing a medical device has online listed the device on the FDA website.

This listing is an administrative procedure and requires only payment and does neither require clearance nor approval for the device. This is only a self-declaration by the manufacturer or person who executes the listing.

 

This is the trick used by some manufacturers to get their name on the FDA website and falsely claiming that their medical device is “cleared” or “approved” by the FDA, which they are of course not.

Massage or biofeedback instead of pemf device

Above are some examples of registrations by some manufacturers of PEMF machines to obtain listing of their company name and PEMF machine name on the FDA website. This is done online by misrepresenting their PEMF device and calling their device either an "electric massage device" or a "biofeedback device" instead of a PEMF machine.

 

Only payment is required to get this simple trick done while clearly misleading the customer with listing statements suggesting that their device is "FDA approved" or "FDA certified" which is simply untrue for a general purpose PEMF device!  


Approval of Medical Devices in Europe

 

The Curatron PEMF machines are approved by health authorities for medical therapy for human applications in Europe according to the Medical Device Directive 93/42/EEC and licensed as medical devices according to Health Canada. The devices are manufactured according to ISO 13485 for Good Manufacturing Practice.