US FDA Ponders Using MDSAP Audit Results In Lieu Of Pre-Approval Facility Inspections

The agency is considering ways to leverage outputs from the increasingly popular Medical Device Single Audit Program in new and diverse ways, including accepting MDSAP audit results instead of conducting its own pre-market approval inspections.

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US FDA is mulling over how it might leverage outputs from the increasingly popular Medical Device Single Audit Program in new and diverse ways, including using MDSAP audit results in lieu of the agency's pre-market approval facility inspections.

Sean Boyd, deputy director for regulatory affairs for the Office of Compliance within FDA's Center for Devices and Radiological Health,...

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