The US Medical Device regulating authority, the Food and Drug Administration (FDA), has issued a Safety Communication to warn all potential users on risks associated with the use of unapproved diagnostic medical devices.


The Products

A current, focal concern is the growing number of smartphone-based software products that are intended to assist the diagnosis of head injuries, connected with changes in the functioning of the brain. These apps can provide an injured person with several tests to perform on themselves to check the current state of their brain functions in order to detect any threatening changes in concentration, speech, and cognitive status. The developers of these softwares claim that they could be used for diagnostic purposes in place of medical devices.The risk is that, some of them are not approved by the FDA. The FDA executes continuous monitoring of the market, evaluating all new devices and studying the documentation and promotional materials describing their functions.


The growth of the use of technological solutions by consumers in healthcare sphere by Liquid State

Risk Evaluation

The highest possible risk related to the use of unapproved diagnostic medical devices is the possibility of an improper diagnosis. For example, if an injured person using such devices were to pass the test and find out that there is no injury, they would not seek additional medical attention. In situations related to head injuries, the lack of proper treatment and care may lead to serious problems. That is why the distribution of such unapproved softwares as medical devices may cause harm to the public health.

Mobile Applications’ Regulation

At the present time, the legislation regulating mobile applications dedicated to medical purposes seems to be in progress. The main principle states that a smartphone operating medical applications shall be treated according to the functions that the such application provides. For example, if the application were to check current heart performance and condition, the application would be regulated as a diagnostic medical device under its appropriate classification. The current classification system under the FDA is that devices are organized by Class I, II, or III — each posing a higher level of risk to the human body, respectively. At the same time, there are many applications that could be excluded from the regulatory scope if they are created for general wellness purposes. The regulating authority also pays attention to the way the developer promotes their application. Some other countries, like Singapore, classify medical applications and Class I medical devices and use informative procedure, which means that the developer should only inform the regulating authority about the marketing of new application, without providing clinical trial results and filing for the approval.


The FDA issues the following recommendations:

  • Always seek professional care and treatment in case of any possible head injury,
  • Be aware of unapproved medical software claimed to be used for diagnostic purposes as it could cause harm to your health.
  • Notify the FDA on any issues related to the medical software,
  • In case of any concerns, visit your health care provider to check your  current health conditions and obtain professional treatment if necessary.

What This Means for Software Developers

The popularity of medical software makes regulating authorities pay additional attention to the use of smartphones for medical purposes. The FDA could possibly impose strict regulation in this sphere in the future, so it is necessary to keep an eye on any upcoming regulations. RegDesk’s platform would inform you on current changes in current legislation for you to prepare to comply with new requirements. Existing regulatory framework suffers substantial changes nowadays. The main goal of our software is to provide our clients operating in the sphere of medical devices development and production with the information on amendments and improvements that may influence their business activity. Reach out to a representative today to learn more!

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