December 14, 2017

FDA Revises Approach to Medical Device Regulation

The U.S. Food and Drug Administration (FDA) published draft guidance, The Least Burdensome Provisions: Concept and Principles on Dec. 15 for a 60-day public comment period.

The draft guidance for medical device regulation implements provisions from the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act prompting updates to the agency’s previous guidance on this topic from 2002.

The FDA’s least burdensome approach involves obtaining “the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.” The document discusses the FDA’s recent policies and programs to reduce regulatory burden and incorporate post-market considerations into premarket decisions. It also addresses clinical and nonclinical data requirements for device submissions and the agency’s extensive global harmonization efforts with international regulatory authorities.

Related to this overarching philosophy, FDA Commissioner Scott Gottlieb announced on Dec. 11 the planned release of a major proposal to update the substantial equivalence determination requirements that are central to the FDA’s 510(k) clearance process. The proposal would involve an optional alternative pathway for mature device types to demonstrate substantial equivalence by meeting certain safety and performance standards. The draft guidance to define this alternate pathway is slated for release in the first quarter of 2018.