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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Seeks to Expand Least Burdensome Principles Across the Total Product Lifecycle

Jan. 3, 2018

The FDA said a “least burdensome” approach should be applied throughout the medical device product lifecycle, rather than just in premarket regulatory decisions.

The agency intends to provide significant updates to its 2002 least burdensome guidance as provisions in the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act of 2016 “further recognized the role of post-market activities as they relate to premarket decisions.”

Agency staff and industry share a responsibility to rely more on post-market activities, such as post-approval studies and post-market surveillance, when using the least burdensome approach in order to ensure timely patient access to safe and effective medical devices, the agency said.

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