July 31, 2017
Authored and Edited by Scott A. Allen; Kathleen A. Daley
In July 2017, FDA released its Digital Health Innovation Action Plan. The Action Plan sets out FDA’s vision for fostering digital health innovations while upholding its mission of protecting and promoting public health. The Action Plan includes three major initiatives.
First, the Action Plan sets forth FDA’s goals and schedules for clarifying the medical device provisions of the 21st Century Cures Act, which removed certain medical device related software from being regulated as medical devices. FDA intends to release draft Guidance at the end of 2017 that will explain, for example, FDA’s policy on mobile medical device applications, low-risk wellness products, and medical image storage devices.
As part of its strategy for clarification, FDA intends to issue, during the first quarter of 2018, draft Guidance that delineates with specificity the types of clinical support software that is no longer under FDA’s jurisdiction. It also plans to release draft Guidance related to FDA’s oversight of products with software functions that simultaneously implicate both medical device regulations and non-medical device regulatory provisions.
Second, the Action Plan announced a pilot precertification program to develop a new approach to FDA’s digital health technology oversight, which FDA is calling FDA Pre-Cert for Software. FDA Pre-Cert for Software could replace the otherwise necessary premarket submission for certain health software products. The pilot program will leverage customer input to develop Pre-Cert for Software that will reduce the time and cost of market entry for software developers that FDA determines reliably manufacture digital health devices, while also providing appropriate patient safeguards. FDA is also considering the role of third-party certification in facilitating FDA determinations about pre-certification.
Finally, FDA announced its intent to strengthen the health expertise within FDA by hiring new staff for the Digital Health Program within CDRH, which will be funded by additional user fees. FDA is also launching an Entrepreneurs in Residence program for thought leaders and other individuals with real-world experience in software development to help build and structure the digital health function within CDRH.
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