February 4, 2018
“Part of our mission to protect and promote the public health means ensuring our regulatory framework supports timely patient access to high quality, safe and effective medical devices. To achieve these goals, we’re focused on new policies that apply modern, science-based and efficient approaches to regulation. This includes reducing or reforming outdated burdens that can add to development costs or forestall beneficial innovations without also adding to our assurance of safety or our knowledge about a product’s benefits,” said FDA Commissioner Scott Gottlieb, M.D. “Today, we’re finalizing guidance that outlines how we’re applying the ‘least burdensome’ means of assuring the safety and effectiveness of medical devices across the total product lifecycle. This applies to how we evaluate novel devices under FDA review and how we accommodate iterative improvements to existing devices already on the market, which can enhance device safety and effectiveness. This ‘least burdensome’ concept has often been misunderstood. The guiding principles outlined in this policy explain our approach to assuring we obtain the minimum information needed to adequately and most efficiently address relevant regulatory questions at the right time in our review of new device technologies, without compromising our stringent review standards, our gold standard for assuring safety, or the scientific integrity of our decision-making process. This balanced method allows us to focus our resources on issues of highest public health concern. In addition, gathering and reviewing information not useful for informing our knowledge about a product’s safety and benefits can impede the collection and review of more relevant information and delay timely patient access to beneficial medical products. We believe that assuring the safety and innovation of medical devices go hand-in-hand. The final guidance we’re issuing today explains how we intend to balance and prioritize both of these fundamental priorities.”
Today, the U.S. Food and Drug Administration issued final guidance for industry, “The Least Burdensome Provisions: Concept and Principles.” This guidance is intended to accurately reflect Congress’ intent by describing the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles.
Since the Food and Drug Administration Modernization Act of 1997 (FDAMA), Congress has directed FDA to take a “least burdensome” approach to aspects of medical device premarket evaluation in a manner that eliminates unnecessary burdens that may delay the marketing of beneficial new products. This approach does not change the applicable regulatory standards, such as the device approval or clearance standards, nor the applicable requirements, including premarket submission content requirements, the requirement for valid scientific evidence, and the FDA’s gold standard for product review.
The FDA defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. This least burdensome definition considers the type of information, different approaches to generating or providing information, and when—during the total product lifecycle—information should be generated or provided to the FDA. This concept applies to all products that meet the statutory definition of a medical device and has been expanded beyond the statutory requirements applicable to premarket review to also address products throughout the total product lifecycle (premarket and postmarket), including device constituent parts of combination products.
This guidance is one of many steps the agency has taken to modernize its review of medical devices and enhance device safety, as outlined in the FDA’s Medical Device Safety Action Plan.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. FDA also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.