FDA Issues Draft Guidance for “Least Burdensome” Approach to Device Regulation

The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”  The FDA provides this draft guidance following a December 2017 Government Accountability Office (GAO) report assessing the FDA’s application of the “least burdensome” approach to regulation.

The least burdensome mandate for medical devices has been a part of the FDA’s governing law since Congress’ passage of the FDA Modernization Act of 1997.  Its intent is to eliminate unnecessary delays for approving new devices, while still maintaining the statutory requirements for approval.   The GAO report found that, between 2013 and 2016, device sponsors had appealed FDA staff decisions to agency management a total of 63 times.  Of these 63 appeals, 33 raised issues related to the FDA’s application of the least burdensome approach, and the FDA at least partially agreed in 11 of these cases.  The GAO report further notes that the FDA has not evaluated its compliance with the least burdensome mandate and suggests the development of performance metrics to meet this end.

FDA Commissioner Scott Gottlieb states that he is “fully committed” to implementing the least burdensome mandate.  The draft guidance defines least burdensome to be the “minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient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.”  The guiding principles espoused in the draft guidance include the FDA’s intent to require the “minimum information necessary to adequately address the regulatory question or issue at hand,” a call for industry sponsors to submit “well-organized, clear, and concise information” for the FDA to review, and the FDA’s commitment to apply regulatory approaches that “fit the technology, taking into account its unique innovation cycles, evidence generation needs, and timely patient access.”

The draft guidance also provides examples of how the least burdensome approach can be applied.  For example, it suggests that:

  • Computer modeling and simulations “should be used to support medical device safety and effectiveness as alternatives to traditional benchtop or animal performance testing in appropriate circumstances.”
  • “Alternative approaches should be considered, when appropriate, to optimize the time and resources of FDA and industry. Both FDA and industry should understand that there are often
    multiple ways to satisfactorily address a particular regulatory issue. The resolution of the regulatory issue should be based on a discussion about which method is least burdensome, while still satisfactorily addressing the regulatory issue.”
  • “Bench performance testing should be considered to address preclinical or clinical endpoints,
    when appropriate. This may include bench models for anatomy, such as evaluating tortuous
    paths for catheters used across many clinical applications.”

This draft guidance will replace an earlier guidance document issued in 2002.  The period for public comment on this draft ends on February 13, 2018.

Mark Davis
Mark Davis is an associate in our Orange County office. His practice is focused on patent litigation and prosecution. Mr. Davis earned his Bachelor of Science in Mechanical Engineering at Brigham Young University, where he competed in the international University Rover Challenge. After graduation, he worked as a regulatory compliance engineer at Novarad, a small medical device company. Following his work as an engineer, Mr. Davis attended the University of Texas School of Law. At Texas, he was an officer in the Texas IP Law Society and served as an associate editor of the Texas Law Review. He also represented small business owners and nonprofit groups as a member of the Texas Clinical Law Programs. He joined the firm in 2015.
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