The Global Harmonization Task Force issued a guidance that provides 17 rules for device classification, according to a MassDevice report.
The guidance provides rules for classification of devices and decision trees to guide those choices. Structural recommendations include using a four-tier system ranging from class A (lowest-hazard devices) to class D (highest-hazard devices); basing classification determinations on a device's potential to harm a patient, its intended use and the technology it uses; accommodating future technological developments in the classification rules and requiring manufacturers to document their justifications.
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The guidance provides rules for classification of devices and decision trees to guide those choices. Structural recommendations include using a four-tier system ranging from class A (lowest-hazard devices) to class D (highest-hazard devices); basing classification determinations on a device's potential to harm a patient, its intended use and the technology it uses; accommodating future technological developments in the classification rules and requiring manufacturers to document their justifications.
Related Articles on Medical Devices:
10 Recent FDA Drug and Medical Device Decisions
Legislators Petition FDA for Faster, Simpler Medical Device Review Process
FDA Issues Two Draft Guidances on Medical Device Development, Studies