FDA To Regulate Some Medical Device Apps

The U.S. Food and Drug Administration announced earlier this month that it would regulate small portions of the growing number of mobile health applications, which are popular on smartphones and tablets.

FDA officials told the New York Times that their goal is to oversee apps that function like medical devices, which could potentially pose risks to patients. Many of the apps targeted are still being developed, and include things like ultrasounds and glucose level readers.

The FDA said that it would not regulate health apps that are used to do things like count calories or help with fitness and weight loss. The Times reported that some apps have already been approved by the FDA, including one that when paired with a special portable device can double as an ultrasound machine.

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

Dr. Joseph M. Smith, chief medical and science officer at West Health Institute, a nonprofit medical research organization, told the Times that the development of some apps have been slowed because of a lack of clarity about how the FDA would treat them.

“This is very welcome news for the innovator and investment community,” Dr. Smith told the Times.

The FDA said that it will consider the apps by the case and will not require clinical trials if the app resembles a medical device already in the marketplace. Apps will be required to face the same standards that apply to the medical devices they resemble. The Times reported that the agency has cleared about 100 mobile medical apps in the last 10 years and about 40 of them in the last two years. None were required to go through clinical trials.

If a defective medical drug or device has injured you, contact our firm today. Our experienced pharmaceutical drug and device lawyers can investigate the negative side effects of any claim you may have. Our firm offers confidential, no obligation consultations.

Zoll & Kranz, LLC – Pharmaceutical Drug and Device Litigation Attorneys