US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles

Draft Guidance for Industry and Food and Drug Administration Staff

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.1 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 FDA 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 This draft guidance is intended to accurately reflect Congress’ intent by describing the guiding principles and recommended approach for FDA staff and industry to facilitate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.

We define “least burdensome” to be the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.

This concept applies to all products that meet the statutory definition of a device and throughout the total product lifecycle (premarket and postmarket).

FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. Throughout this guidance document, the terms we, us and our refer to FDA staff from the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) involved in device regulation.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

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