The Role of Medical Affairs/Medical Safety in Medical Device Post-Market Risk Assessment & Management
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The U.S. Food & Drug Administration (FDA) and other global regulatory agencies provide risk classifications for approximately 1,700 categories of medical technologies/devices across 16 medical specialties. Based on intended use, indications for use, and the risk that the technology may pose to the patient/user, the FDA classifies devices as Class I (highest risk), Class II (moderate risk), or Class III (lowest risk), with these classes largely determining controls and premarket approvals required to earn regulatory approval. (Canada considers four risk classes and Europe uses three risk classes with the Class II split into IIa and IIb. While this paper most specifically addresses U.S. requirements, recommended strategies are applicable globally.)
