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FDA moves to speed device approval process
Modern Healthcare

Some medical devices could move through the Food and Drug Administration approval process faster under changes in the 510(k) program the agency announced today.

For instance, the agency plans to streamline the “de novo” review process for certain innovative, lower-risk medical devices and establish a new Center Science Council of senior FDA experts to ensure timely and consistent science-based decision making. Those initiatives are part of a 25-point plan the FDA intends to implement in 2011 to expedite approvals for most types of medical devices.