The core audit standards for MDSAP (Medical Device Single Audit Program) certification in the United States are primarily based on the following key regulatory requirements:

1. FDA Quality System Regulation (QSR) - 21 CFR Part 820: This is the primary standard for medical device manufacturers in the United States. It covers all aspects of the quality management system (QMS), including design controls, production and process controls, corrective and preventive actions (CAPA), and records management.

2. ISO 13485:2016: This international standard for quality management systems is used as a basis for the MDSAP audit. ISO 13485 is closely aligned with the FDA's QSR but offers a broader framework that applies to multiple countries' regulations.

3. FDA Medical Device Reporting (MDR) Requirements - 21 CFR Part 803: This regulation governs the reporting of adverse events and device-related incidents. Manufacturers must have a system in place to monitor, report, and investigate adverse events, as well as product corrections or recalls.

4. FDA Labeling Requirements - 21 CFR Part 801: The FDA has specific regulations for labeling of medical devices, which ensure that the product labels provide accurate and necessary information for users. This includes instructions for use (IFU), warnings, and claims.

5. FDA Risk Management Requirements: As part of the quality system, manufacturers must implement risk management practices in accordance with ISO 14971, which applies to risk assessment and mitigation during the lifecycle of the device.

MDSAP auditors evaluate a company’s compliance with these standards during the audit process. The audit is designed to assess whether a manufacturer’s quality system meets the regulatory requirements of the participating MDSAP countries, including the United States.

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