John William Schaefer - Comment

The current 510(k) process encompasses a wide range of risk levels, extending from non-patient-contact, disposable plastic equipment-contamination-prevention covers to highly critical invasive and diagnostic systems. The revised process should be multi-tiered based on risk categorization and risk analysis, with higher risk, highly critical devices subjected to considerably strengthened evaluation. Filing fees also should be scaled by risk tier so that sufficient funding is available to conduct those more intensive evaluations of higher-risk devices. The existing Product Code system is overly complex, based on conflicting rationales, duplicative in multiple areas, and broadly inconsistent with rest-of-world classification approaches in ways that are not justifiable based on safety and effectiveness. Some proportion of the dysfunctionality of the current 510(k) system comes from the workload resulting from low-risk Class II devices. Perhaps it would make sense to shift some Product Codes to Class I when they do not involve patient contact or more broadly when they are low risk. Or, perhaps it would make sense to move to a harmonized approach, to create a better foundation for the revised 510(k) system.