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Goal 3: Support FDA’s Decision-Making Authority on Medical Device Safety

The U.S. Food and Drug Administration’s (FDA) 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. The 510(k) process provides FDA the flexibility it needs to ensure the safety and effectiveness of medical devices whose risks are well-understood from experience with similar devices.

The 510(k) review process provides for thorough FDA review of a wide range of devices in a timely fashion that facilitates patient access to needed medical advances.