510(k) Reform and the Resulting Impact on Medical Device Developers

510(k) Reform

Strategies on 510(k) Premarket Reform

The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) issued draft guidances to revise its 510(k) premarket notification process for medical devices. The revisions aim to bring efficiencies and predictability to the approval process while ensuring device efficacy and safety. This paper reviews 510(k) reform implications for sponsors, with a focus on four key draft guidances.

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