Why This Course is Important
Without this course, you risk overlooking key compliance requirements, potentially facing regulatory delays, reclassification to class III, or market removal for non-compliance.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer.
Key regulatory references include:
Course SKU
FR-26-3296-1