New Least Burdensome Guidance

By Kinsey S. Reagan

FDA today posted new draft guidance The Least Burdensome Provisions: Concept and Principles  (December 15, 2017) addressing the “least burdensome” approach to medical device regulation.  The new guidance would replace prior guidance issued in 2002.

The new guidance would apply “least burdensome” principles to all regulatory activities pertaining to medical devices, including both premarket and postmarket actions.  The Federal Food, Drug, and Cosmetic Act has required the “least burdensome” means of complying with certain enumerated statutory provisions concerning devices since enactment of the Food and Drug Administration Modernization Act in 1997.  Most recently, the 21st Century Cures Act added enhanced provisions adopting the “least burdensome” approach, including requirements for training and oversight of FDA employees and auditing by an FDA ombudsman of the effectiveness of the training.  The new law also mandates that Agency summaries of significant device regulatory decisions describe how “least burdensome” requirements were considered in the action.

Under the draft guidance, FDA would define “least burdensome” to mean the “minimum amount of information necessary to adequately address a regulatory question or issue though the most efficient manner at the right time.”  These criteria and the key terms (e.g., “minimum,” “adequately,” “efficient,” “right time”) clearly require the exercise of judgment on the part of FDA regulators.  The guidance indicates that the Agency will conduct regulatory training of all affected employees on the “least burdensome” principles.  The guidance also notes the industry plays a part and should submit material, including premarket submissions, to FDA that are least burdensome for FDA to review (e.g., well-organized, clear and concise).

The draft guidance provides numerous examples and a detailed discussion of the application of these principles to various areas of medical device regulation, including sources of clinical data, use of non-clinical data, and reducing the burden of traditional clinical studies.  The definition of “least burdensome” includes the element of imposing information requirements at the “right time” in the regulatory process or product lifecycle.  The guidance addresses the “right time” aspect in a discussion of the appropriate balance between requiring premarket information versus postmarket information in order to meet regulatory needs.

FDA requests that comments and suggestions on the draft guidance be submitted within 60 days of publication in the Federal Register (which is scheduled for December 15, 2017).