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FDA to improve 510(k) approval process

The US Food and Drug Administration (FDA) has launched a plan containing 25 actions it intends to implement in 2011 to improve the 510(k) process - which is the most common review path for medical devices.

The key actions include streamlining the review process for certain innovative, lower-risk medical devices, clarifying when clinical data should be submitted, and establishing a new centre of senior FDA experts to ensure better decision making.

FDA Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren said these actions will result in a smarter medical device programme that supports innovation, improves job prospects, and brings safe and effective technologies to patients quickly.

This move comes after the CRDH sought public input and review from Institute of Medicine to address the concerns related to the 510(k) process.

After reviewing public comment, CRDH now intends to implement 25 actions to improve the process, and following the feedback from the Institute of Medicine, the Centre will take the final decision.