A new rule has been recommended in the Federal Register, which would change mobile health technology classifications.
The Food and Drug Administration has now proposed a new rule within the Federal Register which would make changes to the way that it would classify mhealth devices, which could be quite beneficial to that industry.
The proposed rule would make it easier for the agency to classify a mobile medical device.
Should this become the rule, it will be simpler for the FDA to be able to classify mhealth devices under 2012’s Food and Drug Administration Safety and Innovation Act. The primary element to the new rule would be the identification of five different categories of medical devices which could be set into the highest class for regulation.
Due to the nature of mhealth technology, the faster it can be classified, the better its chances for success.
The five categories of medical devices that were identified in the proposed rule are:
• Devices with an unfavorable or unknown profile for risk vs. benefits;
• Devices that have known risks that cannot be controlled;
• Devices for which a complete manufacturing information review will be required;
• Devices that will need to obtain a premarket review whenever any change is made that could affect its effectiveness or safety; and
• Combination products that include a biological or drug product that must have its effectiveness and safety verified.
According to the mHealth Regulatory Coalition general counsel, Bradley Merrill Thompson, this proposed rule could be quite advantageous to mobile health care. He explained that until now there has been a notable struggle, as the majority of new mobile devices that are designed to function as health products “do not fit squarely into the old classification system.”
He also pointed out that because of that and as there have not been any regulations for classifications that define the “new categories and the associated regulatory pathways,” there has been a great deal of frustration and delay for mhealth product developers. This could provide them with a new way to be able to navigate the system for FDA classification, which would be tremendously beneficial.