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FDA to streamline path for medical device review. |
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FDA: The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices. Key actions include: ........................ * Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,................... * Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process,..................... * Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.
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