FDA Issues Final Guidance on Least Burdensome Provisions for Medical Devices

Congress has directed the FDA to conduct premarket evaluations of medical devices in the least burdensome manner possible, consistent with maintaining the statutory requirements for clearance and approval. As a result, the FDA recently issued a final guidance document titled “The Least Burdensome Provisions: Concept and Principles.” Congress first added a least burdensome provision to the Federal Food, Drug & Cosmetic Act in 1997, and more recently in the FDA Safety and Innovation Act and in the 21st Century Cures Act.