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Jon Dobson
July 27, 2017

AdvaMed Statement On FDA’s Digital Health Innovation Action Plan and Pre-Cert Software Pilot Program

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today issued the following statement from Janet Trunzo, senior executive vice president, technology and regulatory affairs, in response to FDA’s latest steps to empower consumers and advance digital health care:

“AdvaMed applauds the release of FDA's digital health innovation action plan and announcement of a pilot for a pre-certification program. AdvaMed Digital Health has been deeply engaged with FDA on the development of the pre-certification program and looks forward to continuing to work on this exciting opportunity. We believe the pre-certification program, if properly implemented, has the potential to reduce pre- and post-market burdens for both software developers and FDA, and enable streamlined changes and modifications to software.

“AdvaMed also commends FDA for its commitment to release guidance concerning implementation of the 21st Century Cures Act, clinical decision support, and devices with multiple functionalities, and final guidance on software modifications. However, we continue to have concerns with the International Medical Device Regulators Forum (IMDRF) clinical evaluation document on software as a medical device (SaMD), which is based on a classification scheme that does not align with FDA’s statutory framework, and do not believe it should be issued as a final guidance by the agency.

“It is essential that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable efficient development of these technologies. We look forward to continuing to work with FDA and Commissioner Scott Gottlieb to expand patient access to advanced digital health technologies that empower consumers and improve patients’ lives.”

About AdvaMed Digital Health:

AdvaMed Digital Health is the home for technology companies that are driving the digital health revolution and reflects AdvaMed’s strategic commitment to being a leading digital health convener and thought leader. AdvaMed Digital Health promotes the benefits of digital health for patients and health care, and advocates for public policies that support the advancement of digital health technologies.