FDA CDRH Gives Itself a Round of Applause

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Government officials sure like stats. In a new report, the Center for Devices and Radiological health says it accomplished 86 percent, or 92 of 107 actions it pledged to complete in Fiscal Year 2010.

Among the highlights, the Center notes it completed and released for public comment two preliminary reports recommending concrete steps it could take to strengthen the 510(k) program and increase the predictability of its use of science in regulatory decision making by fostering medical device innovation, enhancing regulatory predictability, and improving patient safety. As we’ve blogged elsewhere, AdvaMed and some others are wary that the agency will stifle medical device innovation if it acts with too heavy a hand here.

CDRH also launched the CDRH Transparency Website; a website which it says will eventually serve as a one-stop-shop for publicly released information about its decisions, as part of the Center’s efforts to increase transparency in its decision making.

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