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The MDSAP (Medical Device Single Audit Program) is an international initiative that allows medical device manufacturers to undergo a single audit of their quality management systems (QMS) to satisfy the regulatory requirements of multiple countries. However, it's important to note that the MDSAP is not specific to the United States alone; it is a global program involving five participating countries: the United States, Canada, Brazil, Japan, and Australia.

For the U.S., the MDSAP audit is intended to help manufacturers meet the requirements of the FDA (Food and Drug Administration) for medical device quality systems under 21 CFR 820. MDSAP is an alternative to conducting separate inspections for each regulatory body, streamlining the process and reducing the audit burden on manufacturers.

The key elements of the MDSAP program for the U.S. include:

1. FDA Requirements: By undergoing MDSAP, manufacturers fulfill the FDA's inspection requirements related to the Quality System Regulation (QSR).

2. Single Audit: The audit conducted under MDSAP covers the requirements of multiple regulatory agencies, so the manufacturer does not need separate audits for each country involved.

3. Third-Party Auditors: MDSAP audits are conducted by recognized third-party organizations, approved by the regulatory bodies, which include not only the FDA but also authorities from other MDSAP member countries.

4. Continuous Monitoring: Manufacturers must maintain compliance with the quality management system standards and submit periodic reports to relevant authorities.

To summarize, MDSAP is a global initiative that simplifies regulatory compliance by allowing medical device manufacturers to undergo one audit that meets the requirements of multiple countries, including the U.S. FDA.

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