Why This Course is Important
Without this course, you risk gaps in compliance knowledge, potential delays in FDA clearance, and increased exposure to enforcement actions or product reclassification.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures.
Key regulatory references include:
Course SKU
FR-26-2197-1