On March 7, the ACC submitted feedback in response to the U.S. Food and Drug Administration's (FDA) proposal to update the De Novo medical device classification process. In these comments, the College urges the agency to ensure regulatory decisions are science-driven by continuing to utilize an evidence-based process to approve novel medical devices.

In 2018, the FDA published the Medical Device Safety Action Plan, outlining a process to reduce the burdens and costs associated with the medical device approval and surveillance process without compromising patient safety. The ACC supports FDA efforts to find the appropriate balance between fostering innovation and protecting public health through a clear and predictable medical device approval process.

The College will continue to work with the FDA to develop transparent, evidence-based medical device review and approval processes, guided by ACC's Health Policy Principles related to digital health and patient access.

Keywords: ACC Advocacy, Patient Safety, Public Health, United States Food and Drug Administration, Device Approval, Health Policy

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