FDA Ready to Act on Digital Health

With the digital world continuing to influence our lives, the Food and Drug Administration has a Health innovation plan to execute. They will be working to introduce more medical applications.

The FDA Application

There are already thousands of medical apps being used in the market. While some help professionals to track health conditions, other assist in diagnostics. The FDA plans on aiming at a small niche, though. They have decided to produce a digit unit which will follow a risk-based approach. This will all be in pursuit of transforming the approach to digital health.

The Process

Everything food and drug related has to pass through FDA to become available in the market. The same applies for most digital health applications, only to make the process more cumbersome. FDA, in the simplest of the terms, wants to digitalize and streamline the process by developing policies a developer could follow on his own.

The FDA will not need to directly go through the medical applications. The developers will have guidelines they would follow, so that the applications developed comply with the FDA standards in the first place. However, only the lower-risk programs will be allowed to penetrate the market without direct FDA scrutiny. As for the high-risk programs, a streamlined premarket review will take place.

Augmented Aids

Dr. Gottlieb—Commissioner, Food and Drugs—said that developers who are known for their top-quality development and maintenance of applications can also be issued certificates that would assess their products. He believes that taking such a measure in the progressing digital age will save both the cost and time of market entry.

Once this effort takes off well, further expansions are to be followed. In a nutshell, the Food and Drug Administration has major regulatory frameworks in place for the digital health market.