AdvaMed defends FDA's 510(k) clearance process for devices

09/23/2009 | Wall Street Journal, The

The FDA said it commissioned the Institute of Medicine to evaluate its 510(k) clearance process for medical devices and also will conduct an internal assessment of the process. AdvaMed called the 510(k) process "a well-defined, science-driven method used by FDA as part of a comprehensive regulatory framework," and advised IOM to include device experts in the evaluation.

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