Why This Course is Important
Without this course, you risk non-compliance with new FDA requirements, potential market delays, regulatory penalties, and missing critical steps to ensure device safety and effectiveness.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction.
Key regulatory references include:
Course SKU
FR-26-2109-1