FDA and NMES

image1

Just the facts

The following facts can be externally validated by FDA legal experts. Any rhetoric that attempts to contradict or does not support the following statements is intentionally misleading and designed to confuse and scare the public. 


Please do not fall prey to fake news produced by profit driven companies. 


image2

Fact # 1

ALL standard electrical stimulation devices on the market have been cleared by the FDA for the following uses: 


  1. muscle re-education 
  2. prevent/retard disuse atrophy 
  3. relax muscle spasm 
  4. increase local blood circulation 
  5. immediate post surgical stimulation of calf muscles to prevent DVT 
  6. maintain or increase ROM

The use of electrical stimulation for The Biber Protocol® program is based on a standard muscle re-education protocol for small muscle groups. 


It is also used for the purpose of preventing or retarding disuse atrophy of the suprahyoid musculature due to inactive periods, i.e. NPO. 


The intended use for this program is within the existing FDA guidelines. 


Any electrotherapy equipment with the ability to be modified for individual programs can be used for this purpose. 


The placement of electrodes is not on the contraindicated portion of the anterior neck area i.e. carotid sinus or laryngeal region but rather on the submental area of the submandibular triangle. This is not only a safer but also a more biologically plausible location.


 The advantage to using standard equipment for this purpose is that the clinician has the freedom to modify the parameters to best meet the patient’s individual needs. This, of course, can be done with adequate training and a thorough understanding of the fundamentals of NMES. 

 


image3

Fact # 2

Fact # 2: FDA also provides the following disclaimer “Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.”


What this means is, if a company tries to “sell” their product by acting like they alone have some sort of special FDA approval, that is considered to be false advertising. 


FDA and the Facts

image4

Fact # 3

There are currently 2 devices (with many more in process) that have been  based on Biber Protocol® and cleared by the FDA for dysphagia.


image5

Fact # 4

There is no difference in any of the devices on the market with regards to safety. All electrical stimulation devices are equally safe and have met the FDA guidelines. They are all considered Class II low risk devices.


image6

Fact # 5

The additional FDA clearance for the treatment of dysphagia using NMES is based on the concept of substantial equivalence. What this means is that ALL electrical stimulation devices are basically equal and can be sold in the US as either a general device for multiple purposes or as a specific device for specific purposes. The devices are exactly the same, it is simply a strategy to capture a particular market. 


The following information is taken directly from the FDA website


A device is substantially equivalent if, in comparison to a predicate device it:


has the same intended use as the predicate device; and 

has the same technological characteristics as the predicate device 

or 

has the same intended use as the predicate device; and 

has different technological characteristics, and the information submitted to FDA; 

does not raise new questions of safety and effectiveness; and 

demonstrates that the device is as safe and effective as the predicate device. 


Substantial equivalence is to be established with respect, but not limited to, intended use, design, energy used / delivered, materials, performance, safety, effectiveness, labeling and other applicable characteristics such as sterility. 


For more information check out https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm284443.pdf



FDA and the Facts

image7

Fact # 6

There is no inherent risk in any device and gaining FDA clearance does not guarantee any absolution of risk. Any potential harm to a patient lies in the hands of an unskilled or misinformed user or in a poorly designed protocol. We are bound by our code of ethics to be competent in the services we provide and to do no harm. 


image8

Fact # 7

The FDA does not “approve” Class II devices so any company claiming they have FDA Approval is falsifying claims. Class I and Class II devices are considered by the FDA to be low risk. They are FDA cleared to market. What this means is the FDA has determined that the electrical stimulator device in question is just like every other electrical stimulator device and can be marketed and sold in the US.  FDA Approval is a much more stringent and lengthy process and reserved for more serious products such as drugs and high-risk medical devices. 


For more information see: https://www.fda.gov:80/FDAgov/AboutFDA/Transparency/Basics/ucm194468.htm


image9

Fact # 8

This is the conclusion of a legal response drafted by an FDA attorney:


In conclusion, FDA places restrictions on the labeling, marketing and promotion of powered muscle stimulators, such that they may only be labeled and promoted in accordance with the approved or cleared indicators for use. Nevertheless, a practitioner may use any approved/cleared powered muscle stimulator for treatment of dysphagia, regardless of the indications for use, when such use is part of the practice of medicine and the practitioner's judgment is in the best interest of the patient. Moreover, FDA does not restrict the dissemination of scientific information on the use of powered muscle stimulators in the treatment of dysphagia, so long as promotion of a particular device is not occurring. 

FDA Attorney Response

To view the entire FDA attorney response click here


FDAposition (pdf)

Download