Stay ahead in medical device innovation with in-depth training on the FDA’s classification of focused ultrasound systems for non-thermal, mechanical tissue ablation. This course unpacks the new class II designation, details every special control under 21 CFR 878.4405, and guides manufacturers and sponsors through the De Novo and 510(k) regulatory pathways. Learn actionable steps for compliance, avoid costly missteps, and ensure your device’s market readiness under the latest FDA requirements.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the device as class II with special controls.
* Identify the specific special controls and general controls applicable to this device type.
* Outline the steps required for compliance, including premarket notification and performance testing.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
