Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants.
FDA’s latest draft guidance on Least Burdensome Provisions will replace guidance on the topic issued in 2002; recently passed US laws including the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act expanded upon Least Burdensome Provision concepts and principles, necessitating revised guidance.
The updated FDA Least Burdensome Provisions apply across all major FDA medical device regulatory activities and processes, including 510(k) premarket notifications, Premarket Approvals (PMA), De Novo requests and Investigational Device Exemptions (IDE).
In addition, the revised provisions cover FDA requests for additional information and major deficiency letters, premarket Q-Submissions, post-market surveillance and reclassification activities.
In short, “The least burdensome concept and this guidance apply to all products that meet the statutory definition of a device,” states the guidance.
Medical device least burdensome provisions entail the minimum amount of data needed to satisfy a regulatory question efficiently and at the right time, according to the guidance. FDA identifies seven guiding principles for both the agency and medical device registrants to follow:
The guidance also provides examples of how FDA as well as US market applicants should apply least burdensome principles in premarket reviews and related regulatory actions. Examples include increasing leverage of existing clinical data, real-world evidence and nonclinical data for premarket reviews, allowing registrants with higher-risk devices to avoid having to conduct new clinical investigations; accepting greater degrees of uncertainty in some benefit-risk assessments; streamlining regulatory processes; and reevaluating regulatory requirements for medical device registrants on a regular basis.