Least Burdensome Webinar and Guidance

Final Guidance and Webinar on the FDA's Least Burdensome Provisions for Medical Device Regulation

Today the FDA issued and posted a final guidance entitled, "The Least Burdensome Provisions: Concept and Principles." This final guidance describes our use of the least burdensome approach to medical device regulation to remove or reduce unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval.  The least burdensome approach ensures that our regulatory framework is appropriately tailored to support timely patient access to high quality, safe and effective medical devices.  The guidance 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 the regulation of medical devices.