The United States Food and Drug Administration recently announced a pre-certification program to show that they are taking the digital health innovations seriously. The FDA selected a total of nine companies as partners to this program. The program's aim is to build a new regulatory process for software used in the prevention, treatment, and diagnosis of medical conditions.
Digital health is the convergence of the digital and genomic revolutions with health, healthcare, living, and society. It’s also helping to reduce inefficiencies in healthcare delivery, improve access, reduce costs, increase quality, and make medicine more personalized and precise.
The nine companies selected for the pilot program are considered to be leaders in the medical device and technology sector. Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche are among the companies that were selected. Samsung being one of the leaders in the healthcare industry, is also the part of the program. However, the program has received interest from more than 100 top brands.
When regulators examine new drug candidates or medical devices, the regulatory road is arduous. Clinical trials are time-consuming and very expensive. The FDA also requires extensive data from every phase of the trial.
The FDA usually looks for how the drug or device performs, often in animals and then in humans. This is to establish that the drug or the device is harmless.
However, with digital health instead of rigorous testing of the software, the FDA will be looking closely at the company behind it. Regulators want to see that the developers of health software are adhering to the highest quality standards and that they are not cutting corners.
This program will focus on the software rather than the end product. The FDA will be reviewing the software design, validation, and maintenance to determine the pre-defined Quality Standards. The FDA will determine key metrics and performance indicators by using the data from the certification program.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products. We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and an agile approach towards the digital health technology that focuses on the software developer rather than an individual product,” said Dr. Gottlieb, Commissioner of the FDA.
The companies that are a part of the program do not need to send their newly developed healthcare devices to the FDA for approval. The FDA launched the pre-certification pilot program on July 27 as a part of its Digital Health Innovation Action Plan.
As part of the program, participants have agreed to provide access to measures they use to develop, test, and maintain their software products. They also have accepted to provide FDA with post-market data. The companies should also be open for site visits from the agency staff. The goal of this partnership is to improve the health measuring and tracking tools as well as software, which will benefit the end users.