FDA Prioritizes Digital Health for 2019
​[Thursday, October 4, 2018]

The list of planned Guidance Documents is a good indicator of FDA’s priorities for the coming year. Each year each center at the FDA publishes the list of Guidance Documents it plans to publish or draft next year. CDRH’s list of Guidance Documents shows that software-based products are the top priority of the Center this year. Five out of 21 Guidance Documents planned to be finalized or drafted in 2019 would discuss software related issues, and a sixth one will draft the FDA’s cybersecurity recommendations. Digital health has been a forefront if FDA’s attention for the last two years. Last year FDA announced its Digital Health Innovation Plan to create a developer-friendly regulatory review process for software-based medical devices. Late last year, FDA announced relaxed the software regulations reducing regulations for several low risk software used in healthcare. Earlier this year FDA launched the software precertification program for developers to get a special pathway to approval. FDA’s strong support for the digital health products has led to a strong market performance and investment in companies developing health-related software. And these initiatives from FDA are set to make it a great year for software developers in the healthcare sector.