Expert: FDA hopes to release ISO guidance by year's end

10/9/2008 | FDAnews

The FDA has held off on issuing a proposed guidance that calls on medical-device makers to voluntarily present International Organization for Standards audit reports, but it hopes to push through with the release by the end of 2008, said an official with the agency's Center for Devices and Radiological Health. Under the FDA Amendments Act, the agency may use ISO audit reports as a basis in deciding which facilities to inspect.

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