The broad scope of digital health includes mobile health, health IT, wearable devices, telehealth and telemedicine, and personalized medicine. Many stakeholders are involved in digital health activities, including patients, healthcare practitioners, researchers, medical device firms, and firms new to FDA regulatory requirements such as mobile application developers.
Led by the Center for Devices and Radiological Health (CDRH) www.fda.gov/medicalDevices within FDA www.fda.gov, CDRH is working to implement the digital health provisions of the 21st Century Cures Act. In the coming months, FDA will be publishing guidance to clarify what falls outside the scope of FDA regulations and also explain how the new statutory provision affects pre-existing FDA policies.
So far, CDRH has established the Digital Health Program and plans to foster outreach to digital health customers, develop and implement regulatory strategies, and develop polices for digital health technologies.
FDA will provide guidance to clarify as to when products containing multiple software functions may fall outside the scope of FDA regulations while others do not. In addition FDA is going to provide new guidance on other technologies not actually addressed in the 21st Century Cures Act, but present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements.
In the June 15th FDA Voice, Scott Gottlieb MD announced a new initiative which is going to be a pilot program that FDA will be undertaking this fall to provide a comprehensive new approach to regulating digital health tools.
As Dr. Gottlieb mentions in the blog, “While the pilot program is still being developed, FDA is considering whether and how under current authorities, the agency can create a third party certification program.”
He further explains, “The certification program might allow lower risk digital health products to be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.”
It would be possible for the certification program to assess whether a company consistently and reliably engages in high quality software design and testing and provides ongoing maintenance for their software products. Employing a unique pre-certification program for software as a medical device could reduce the time and cost of market entry for digital health technologies.
Go to https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices for the June 15, 2017 blog.