Why This Course is Important
Without this course, you risk missing critical updates to FDA requirements for STI diagnostic systems, potentially exposing your organization to recalls, import detentions, or lost market access due to non-compliance.
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 System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens.
Key regulatory references include:
Course SKU
FR-26-3259-1