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FDA Issues Work Plan For Independent Assessment Of Pre-market Review Process

The assessment, called for by industry during the device user fee reauthorization, will be conducted by an independent consulting firm. The goal is to identify efficiencies in the device review process.

FDA is preparing to have a private, independent consulting firm assess its management of the device pre-market review process. On Dec. 19, the agency issued a statement of work plan for the assessment and opened a 30-day comment period to obtain industry feedback.

It was the device industry that originally called for the assessment, gaining FDA's promise to take the step during negotiations over this year's user fee reauthorization. The assessment will be...

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