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FDA Issues Guidance on Least Burdensome Regulatory Approach for Medical/Dental Devices

The United States Food and Drug Administration (FDA) has issued guidance on its use of the least burdensome approach to medical/dental 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 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 medical/dental devices.  To read the FDA guidance on its least burdensome principles for regulation of medical/dental devices, use the link below.