Stakeholders will have an extra month to comment on how US FDA should apply the "least burdensome" concept in device regulation, the agency announced Jan. 23.
In FDA device regulation, "least burdensome" signifies an approach that seeks to minimize unnecessary steps and requests on the part of regulators or industry. The concept has existed for some two decades, but 2016's 21st Century Cures Act required FDA to put it to work in some new ways. Specifically, the law mandated the agency train staff on least burdensome principles; to undergo an ombudsman audit of its practices; and ensure the approach is applied during certain parts of PMA review
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