The US Food and Drug Administration (FDA) is launching a less restrictive regulatory framework for a number of pre-selected companies.
The agency, which oversees drugs, medical devices and most of US food supply, said Tuesday it is working with nine major tech companies. This includes Apple, Fitbit, Samsung, Verily Life Sciences, Roche and Johnson & Johnson.
The program is designed to allow pre-selected companies a way of avoiding lengthy and expensive procedures required for FDA approval, while the government retains oversight of the process. More than 100 companies were interested in the pilot.
With these changes, the FDA is looking to create a more tailored approach toward digital health software and hardware. Instead of approving products, the new process approves companies to make sure they meet the agency’s quality standards.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said Scott Gottlieb, the FDA commissioner, in a statement.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate.”
Sensor technology is advancing steadily and companies such as Apple and Fitbit are showing increasing interest in the medical space. For example, at its recent Apple Watch Series 3 launch, the Cupertino outfit announced a new study to detect atrial fibrillation and abnormal heart rhythms. The company said it was working with the FDA on the program.
Fitbit is also hard at work researching ways in which its heart rate sensor can be used to identify medical conditions. In his key-note presentation during IFA earlier this month, Fitbit’s CEO James Park made a big show about the companies future plans in the medical arena. The new Fitbit Ionic has a SpO2 sensor, which could be used to detect sleep apnea in the future.
Essential reading: Top fitness trackers and health gadgets for 2017
The FDA will use the pilot program to assess if its possible for a select group companies to submit less information when seeking market approval for a product. It is even be possible that some products could skip this process all together.
Like this article? Subscribe to our monthly newsletter to never miss out!