The Food and Drug Administration (FDA) is committed to helping patients gain more timely access to new medical devices and to maintaining continued access to existing medical devices that are high quality, safe and effective, by expediting their development, assessment, review, and surveillance, consistent with the Agency’s statutory mission to protect and promote the public health. By streamlining regulatory processes and removing or reducing unnecessary burdens associated with FDA regulatory activities, patients can have earlier and continued access
to beneficial products.
Since the Food and Drug Administration Modernization Act of 1997 (FDAMA), Congress has directed FDA to take a least burdensome approach to medical device premarket evaluation in a manner that eliminates unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. 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
We define “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 FDA. This concept applies to all products that meet the statutory definition of a device and throughout the total product lifecycle (premarket and postmarket).