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FDA Kills ISO Voluntary Audit Program As MDSAP Efforts Accelerate

The agency has terminated a 2012-launched ISO 13485 voluntary audit program, which gave companies the chance for a one-year reprieve from an FDA inspection, to put all attention on the global Medical Device Single Audit Program.

In an anticipated move, FDA has terminated its three-year-old device ISO 13485 Voluntary Audit Report Pilot program to put all its eggs in the global Medical Device Single Audit Program (MDSAP) basket.

The agency announced the end of the ISO voluntary audit program in a Dec. 17 notice

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