The U.S. Food and Drug Administration (FDA) has drafted a set of guidelines designed to improve the regulatory path for bringing new products to market while also maintaining safety requirements.
Titled "The Least Burdensome Provisions: Concept and Principles," the guidelines would eliminate unnecessary burdens that might delay the approval of beneficial products and provide a more consistent application of the agency's principles for medical devices.
In the proposal, the FDA defines "least burdensome" as 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 includes examples of both premarket and postmarket approaches that the FDA and the medical industry can take to ensure that the least burdensome guidelines are in place for all device-related submissions and dealings with the agency.
The agency will take comments on its proposal for 60 days.
