Course: Proposed Rule on Profits and Related Basis Adjustments based on this document from the Federal Register: https://www.govinfo.gov/content/pkg/FR-2024-12-02/pdf/2024-27227.pdf This document contains proposed regulations regarding previously taxed earnings and...
FDA’s Class II Classification: Whole Exome Sequencing Devices
Discover the significant implications of the FDA’s decision to classify whole exome sequencing devices into Class II with special controls. This course provides comprehensive insights into the regulatory framework and what it means for the safety, effectiveness, and innovation in the field of medical devices.
In this course you will learn the following:
* Understand the classification process and criteria for the whole exome sequencing constituent device.
* Identify the special controls required for compliance.
* Recognize the potential risks and mitigation measures associated with the device.
Additional information
| Federal Register Title | Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device. Document Number: 2024-20550 |
|---|---|
| Course SKU | FR-24-228-1 |
| Why This Course Is Important | Without this course, learners risk misunderstanding the critical compliance requirements, possibly resulting in regulatory setbacks and limited market access for new medical technologies. |