Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Shared Certificates and Pooled Hiring Actions. Document Number: 2026-18828
Buy this Course
FR-26-2208-1
FDA’s Classification of Cellular Analysis Systems
$9.99
Discover the critical implications of the FDA’s recent classification of cellular analysis systems for antimicrobial susceptibility testing. This course offers in-depth insights into the criteria, special controls, and benefits that ensure device safety and regulatory compliance.
In this course you will learn the following:
* Understand the classification process and criteria for the cellular analysis system.
* Identify the special controls required for compliance.
* Recognize the benefits of the De Novo classification process in reducing regulatory burdens.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
Why This Course is Important
Without this course, you risk non-compliance with FDA regulations, potentially leading to costly delays in device approval and market access.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing.
Key regulatory references include:
Course SKU
FR-25-1387-1