“When the Food and Drug Administration recently granted marketing authorization for two medical apps for Apple’s new iWatch 4, it marked a significant step forward for the agency’s overall approach to the development of digital health…”
“As described in existing guidance, the FDA generally reviews medical apps without reviewing the general purpose computing platform they sit upon…”
“The FDA’s approach to digital health isn’t to regulate the every-day health and lifestyle uses of consumer devices, but rather to focus our resources on reviewing more sophisticated medical apps that sit on top of this general purpose hardware – the functions that have greater ramifications for patient health and where ensuring safety and efficacy of the application is critical. By focusing our review on the functionality of the software, our aim is to encourage greater innovation in digital health, including the use of Artificial Intelligence (AI) and clinical decision support software…”
“Our review program offers a number of opportunities for companies to reduce review times. For example, we regularly encourage companies to interact with the agency early in their development process, such as through our Q-Submission (QSub) process to help with efficient development of products…” Read the full article here.
Source: FDA Budget Matters: Advancing Innovation in Digital Health – September 26, 2018, FDA.gov.
