Draft Guidance on Least Burdensome Provisions

Today the FDA posted draft guidance entitled The Least Burdensome Provisions: Concept and Principles. This draft guidance describes our use of least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval.  This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to medical devices.

The FDA believes that least burdensome principles should be widely applied to all activities in the premarket and postmarket settings to remove or reduce unnecessary burdens so that patients can have earlier and continued access to high quality, safe, and effective devices. This draft guidance is being issued to assist with implementation of the updated least burdensome provisions in the 21st Century Cures Act and reflects FDA’s belief that least burdensome principles should be applied throughout the medical device total product lifecycle.

FDA defines least burdensome to be the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time. The principles are based on sound science, the intent of the law, the use of alternative approaches, and the efficient use of resources to effectively address regulatory issues. The guidance includes both premarket and postmarket examples to demonstrate approaches that FDA and industry can take to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.

The comment period for this draft guidance document will be 60 days.

For more information about CDRH activities related to least burdensome, please contact CDRH-Guidance@fda.hhs.gov.