The FDA’s proposal to reclassify in situ hybridization (ISH) test systems from Class III to Class II is set to transform the regulatory landscape for oncology diagnostics. This course offers comprehensive insights into the proposed regulatory framework, the supporting data, and the expected impacts on manufacturers, healthcare providers, and patients. Participants will learn about the special controls necessary for ISH devices and how stakeholder feedback can shape the final ruling.
In this course you will learn the following:
* Understand the purpose and intent of the proposed reclassification.
* Recognize the opportunities for public participation and feedback.
* Identify the potential changes and implications of the proposed rule.
FDA’s Proposed Reclassification of ISH Test Systems
$49.99
1 year of access
Course Content
FDA’s Proposed Reclassification of ISH Test Systems
