FDA Least Burdensome Principles Draft Guidance

On Dec. 14, 2017, the FDA released a Draft guidance dated Dec. 15, 2017 “The Least Burdensome Provisions: Concept and Principles.” This guidance discusses FDA’s intent and approach to applying Least Burdensome Principles to the total product lifecycle for medical devices based on requirements in FDAMA (Public Law 105-115), the FDA Safety and Innovation Act (Public Law 112-144) (FDASIA) ,and the 21st Century Cures Act (Public Law 114-255) (Cures Act). This guidance stresses interactive approaches, tailored approaches, consideration of time and resources impact of its requests, use of post market data to reduce premarket data, timely patient access, leveraging internation data, alternative source of data versus clinical trial data, leveraging existing data rather then running new trials, use of read world data and non-clinical data and bench testing, use of computer modeling and simulation, non-comparative clinical outcome studies, risk benefit analysis, bundling multiple devices in a submission, exempting some Class I and II devices from 510(k) requirements, and in general requesting only the minimum information needed for making a regulatory decision. The full guidance is at the link provided. 1332-DRAFT-Least Burdensome-2017

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

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