EMERGO SUMMARY OF KEY POINTS:

• US FDA has updated guidance on how least burdensome provisions are applied to medical device registration and oversight.
• The new guidance applies across all aspects of FDA medical device regulation.
• The FDA’s least burdensome approach may lead to less onerous US market authorization requirements for some manufacturers.

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FDA’s latest draft guidance on Least Burdensome Provisions will replace guidance on the topic issued in 2002; recently passed US laws including the FDA Safety and Innovation Act (FDASIA)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 21^st Century Cures Act expanded upon Least Burdensome Provision concepts and principles, necessitating revised guidance.

Broader scope of applicability

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.

Seven key Least Burdensome Provision principles

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:

• FDA will request the minimum information needed to address regulatory questions or issues;
• US market applicants should submit materials that are least burdensome for FDA reviewers to assess;
• FDA will utilize most efficient means to resolve any regulatory questions or issues;
• Correct information should be provided at the right time to address the right questions;
• Regulatory approaches and methods should align with technology and timely patient access considerations;
• FDA should leverage data and regulatory decisions from other market regulators where appropriate;
• FDA should apply least burdensome principles to international medical device regulatory harmonization and convergence efforts.

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.

Related US FDA medical device regulatory information from Emergo:

• US FDA 510(k) consulting for medical device and IVD companies
• US FDA QSR (21 CFR Part 820) consulting for medical device companies
• Regulatory process chart: US medical device registration
• Video overview: Introduction to the FDA medical device regulatory process