From Clearance to Clinic: Understanding FDA 510(k) Clearance Pathway and Patient Risk by Kerryann McAnistan

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Budget

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Training Curriculum

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Keynote Speaker Bio | Jeanne Lenzer

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Introduction-FDA-Regulation-of-Medical-Devices-slides

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How-is-CDRH-structured-slides

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Keynote Speaker | David A. Kessler, M.D.

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Is My Product a Medical Device?

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How Is My Medical Device Classified?

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Case Study: How Is My Medical Device Classified?

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The 510(k) Program

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The Special 510(k) Program: Final Guidance

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Quality in 510(k) Review Program Pilot

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510(k) Third-Party Review Program

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Webinar – 510(k) Third Party Review Program: Final Guidance

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Tips and Tricks: Starting Your Own Continuing Medical Education Course

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Continuing Medical Education Activity Application

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CME Training Curriculum

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Literature Review:

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LIVE WEBINAR

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510(k) Third-Party Review Program Overview

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CME Certificate

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Course Invite/Keynote Speaker

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510(k) vs PMA Guide

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FDA Classification Flowchart

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Device “Red Flags” Checklist

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Educational Tools

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Translation to Practice Plan Timeline

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Phase I:

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Evidence & Curriculum Design Months 1–6
Literature synthesis, learning objectives, CME framework

Phase II

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•CME Accreditation & Funding Months 7–8
Accreditation application, budget alignment

Phase III

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•Course Development Months 9–10
Module creation, instructional design, checklist integration

Phase IV

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Platform Integration & Pilot Launch Months 11–14
LMS integration + 510k Academy website (LIVE)

Phase V

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Evaluation & Outcomes Measurement Months 15–18
Pre/post testing, knowledge gain, clinical impact

Phase VI

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Expansion & Partnerships Ongoing
Academic, clinical, and industry collaboration

Phase VII

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Dissemination & Keynote Engagement Ongoing
Conference presentation, keynote speakers, national reach

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The impact of patient, intervention, comparison, outcome (PICO) as a search strategy tool on literature search quality: a systematic review

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