Medical Apps for Smartphones May Be Considered Medical Devices

A recent slew of medical applications intended for smart phones have caused the FDA to take notice. There are currently numerous free or almost free apps available to download, used for everything from reminding you to refill a prescription to monitoring a diabetic's blood glucose levels. Consumers and medical providers see them as easy and inexpensive medical support tools, but the FDA is concerned that they may be too readily available and may not warn users about potential complications.

A simple example can help the problem come into focus. A patient who needs to take heart medication every three hours to prevent cardiac arrest downloads a drug manufacturer's medical application, intended to provide an alarm every time she must take her next dosage. The patient becomes reliant on the application, but an unexpected glitch causes it to miss a notification. The possibility that the patient then forgets to take her pills and falls ill may seem far-fetched, but it is technically possible.

For this, among other, reasons, the FDA is attempting to classify medical applications for smartphones as medical devices which, by law, require FDA approval before being made available to the public. The hope is that the process will weed out faulty or misleading applications and, in the long run, protect consumer's health, despite causing delayed releases and potentially increased costs.

The team of medical injury attorneys at Arnold & Itkin welcomes the move by the FDA to impose more stringent regulations on manufacturers of medically related devises. We have met countless individuals who have been injured by dangerous drugs and defective medical products, and have come to realize that many of these injuries could be avoided with enforced disclosure of potential defects or adverse side effects. If you or someone you know has been injured by a dangerous drug or medical device, regardless of whether it was FDA approved, you may be entitled to compensation. Contact a medical injury attorney from Arnold & Itkin today for a free review of your potential case.