# Phlebotomy Exam Prep 76, FDA Device Regulation in Lab

Page: https://stenobird.com/podcast/nursing-healthcare-exam-prep-7652377/phlebotomy-exam-prep-76-fda-device-regulation-in-lab
Text version: https://stenobird.com/podcast/nursing-healthcare-exam-prep-7652377/phlebotomy-exam-prep-76-fda-device-regulation-in-lab.md
Podcast: [Nursing & Healthcare Exam Prep](https://stenobird.com/podcast/nursing-healthcare-exam-prep-7652377)
Published: 2026-07-11T22:25:11+00:00
Episode link: https://open-exam-prep.com/
Audio file: https://episodes.captivate.fm/episode/1b497efc-fc5b-4eb5-904c-87f543b152bf.mp3
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JSON: https://stenobird.com/v1/public/podcasts/nursing-healthcare-exam-prep-7652377/episodes/phlebotomy-exam-prep-76-fda-device-regulation-in-lab
Duration seconds: 190

## Resource

This podcast is made by Ran Chen, who holds an EA license, Insurance and Securities licenses (Series 6, 63, 65), and the CFP® designation. He is passionate about opening access to high-quality exam preparation resources and helping learners prepare more effectively for professional certification exams. In this episode you will learn: - Differentiate between FDA Class I (low-risk), II (moderate-risk), and III (high-risk) medical devices using phlebotomy-specific examples. - Understand that most common phlebotomy supplies, like collection tubes and analyzers, are categorized as Class II devices. - Grasp the purpose of the 510(k) clearance process, which ensures a new device is substantially equivalent to an existing one. - Master the critical steps for handling a device recall: identifying, quarantining, and documenting affected lot numbers. - Recognize why checking expiration dates on supplies like vacuum tubes is a crucial, non-negotiable step for patient safety and sample integrity. For more free exam prep tools, practice questions, and AI-powered explanations, visit https://open-exam-prep.com/ or YouTube Channel: https://www.youtube.com/@Open-exam-prep

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## Transcript

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