Presentation
MDD25 - Practical Application of IFU Scorecard
SessionPoster Session 1
DescriptionBold Insight has developed a framework for HF practitioners to evaluate their IFU and understand areas to improve based off regulatory guidance. Regulators continue to focus on labeling, including instructions for use, as a source of potential use error. As many as 70% of HF practitioners cite IFU design and content as one of the most common drivers of FDA requests for additional information when reviewing HF protocols and submissions
This work includes prescriptive and directional recommendations based on FDA (CDER) draft guidance, ANSI/AAMI HE75:2009/(R2018), ISO/IEEE 82079-1, and AAMI-IEC TIR 49 on the content and format of IFUs. Particularly for the prescriptive guidance, industry feedback indicates that because IFUs can take on different formats and media, not all of the recommendations in the guidance document would align with best practices in instructional and user-centered design.
We have developed our IFU scorecard to account for this flexibility. For all prescriptive recommendations, IFUs are assessed both for strict adherence to the guidance (adheres or does not adhere), as well as compliance with the principles of user-centered design that are the basis for the prescriptive recommendation.
This poster will illustrate a practical application of the IFU scorecard using a generic or on the market IFU.
This work includes prescriptive and directional recommendations based on FDA (CDER) draft guidance, ANSI/AAMI HE75:2009/(R2018), ISO/IEEE 82079-1, and AAMI-IEC TIR 49 on the content and format of IFUs. Particularly for the prescriptive guidance, industry feedback indicates that because IFUs can take on different formats and media, not all of the recommendations in the guidance document would align with best practices in instructional and user-centered design.
We have developed our IFU scorecard to account for this flexibility. For all prescriptive recommendations, IFUs are assessed both for strict adherence to the guidance (adheres or does not adhere), as well as compliance with the principles of user-centered design that are the basis for the prescriptive recommendation.
This poster will illustrate a practical application of the IFU scorecard using a generic or on the market IFU.
Event Type
Poster Presentation
TimeMonday, March 314:45pm - 6:15pm EDT
LocationFrontenac Foyer
Digital Health (DH)
Simulation and Education (SE)
Hospital Environments (HE)
Medical and Drug Delivery Devices (MDD)
Patient Safety and Research Initiatives (PS)