Medical Devices

Digital Health

The 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions.

The FDA is currently developing draft guidance for public comment to help industry and FDA staff understand how the 21st Century Cures Act affects FDA's oversight of medical device software. If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email


The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.

Providers and other stakeholders are using digital health in their efforts to:

  • Reduce inefficiencies, 
  • Improve access,
  • Reduce costs,
  • Increase quality, and,
  • Make medicine more personalized for patients.

Patients and consumers can use digital health to better manage and track their health and wellness related activities.

The use of technologies such as smart phones, social networks and internet applications is not only changing the way we communicate, but is also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes.

Why is the FDA focusing on Digital Health?

Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored.

Many stakeholders are involved in digital health activities, including patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers.

FDA’s Center for Devices and Radiological Health is excited about these advances and the convergence of medical devices with connectivity and consumer technology. The following are topics in the digital health field on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks:

  • Wireless Medical Devices
  • Mobile medical apps
  • Health IT
  • Telemedicine 
  • Medical Device Data Systems 
  • Medical device Interoperability 
  • Software as a Medical Device (SaMD)
  • General Wellness 
  • Cybersecurity

How is the FDA advancing Digital Health?

CDRH has established the Digital Health Program which seeks to better protect and promote public health and provide continued regulatory clarity by:

  • Fostering collaborations and enhancing outreach to digital health customers, and 
  • Developing and implementing regulatory strategies and policies for digital health technologies.

Federal Trade Commission (FTC) Mobile Health Apps Interactive Tool

If you are developing a mobile health app that collects, creates, or shares consumer information, click on the button to take you to the tool on Federal Trade Commission’s website to find out when FDA, Federal Trade Commission (FTC) or Office of Civil Rights (OCR) laws apply:

Developing a mobile health app? Find out which federal laws you need to follow.

For more information, see FTC's Press Release or visit our Mobile Medical Applications page.

Page Last Updated: 09/06/2017
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