Posted by Michael Wonder on 16 Jan 2018
Statement from FDA Commissioner in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
16 January 2018 - To encourage innovation and provide patients with access to the latest safe and effective medical technologies, we continually strive to make the device development and regulatory review process more modern, science-based and efficient.
A key feature of these efforts is early and more thorough engagement with innovators to help them meet the FDA’s science-based requirements in a way that allows companies to bring safe, effective modern devices to patients as soon as possible.
This approach is one aspect of what we refer to as “least burdensome.”
