Stay ahead of regulatory changes with this in-depth course focused on the FDA’s classification of digital cervical cytology slide imaging systems powered by artificial intelligence algorithms. Learn the specific compliance obligations, required labeling, and design validation steps needed to meet the new class II special controls. Perfect for professionals managing regulatory strategy, device design, and clinical compliance, this course ensures you’re prepared for successful 510(k) submissions and ongoing FDA audits.
In this course you will learn the following:
* Understand the FDA’s classification of digital cervical cytology slide imaging systems with AI algorithm and the rationale for class II designation.
* Identify and interpret the special controls and general controls applicable to these devices.
* Implement the required labeling, design verification, validation, and performance testing measures.
* Recognize the regulatory pathways for market entry and ongoing compliance.
* Understand the legal and financial consequences of failing to comply with the final rule.
