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FDA, Global Partners Prepare To Ramp Up Single-Audit Program

FDA is strongly encouraging manufacturers to participate in the Medical Device Single Audit Program, set to launch in a pilot phase by June. An agency official points to strong global incentives, particularly for firms pursuing the Brazil and Canada markets.

The multicountry Medical Device Single Audit Program is almost ready to get off the ground, and FDA, along with three other regulators, is making efforts to ensure that manufacturers sign up to participate.

The four countries initially participating in MDSAP have begun assessing the applications of third-party auditing organizations, some of which they...

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