Two Paths to Quality System Oversight
Medical device manufacturers selling in the U.S. and Canada face quality system audits from regulatory bodies. There are two main frameworks: traditional FDA inspections and the Medical Device Single Audit Program (MDSAP).
Traditional FDA Inspections
FDA inspects device facilities under 21 CFR Part 820 (Quality System Regulation, now transitioning to QMSR). Inspections can be:
- Routine surveillance — scheduled based on risk and inspection history
- For-cause — triggered by complaints, adverse events, or import alerts
- Pre-approval — tied to a specific submission (PMA, 510(k) for high-risk devices)
What Inspectors Look For
- Design controls and DHF completeness
- CAPA (Corrective and Preventive Action) effectiveness
- Complaint handling and MDR reporting
- Supplier controls
- Production and process controls
Outcome: Form 483
If inspectors find objectionable conditions, they issue a Form 483 listing their observations. Manufacturers must respond with corrective actions. Unresolved issues can escalate to a Warning Letter.
MDSAP: The Single Audit Program
MDSAP was created to allow a single audit to satisfy the regulatory requirements of multiple countries. Participating regulatory bodies include:
- FDA (United States)
- Health Canada
- ANVISA (Brazil)
- TGA (Australia)
- PMDA (Japan)
Audits are conducted by Auditing Organizations (AOs) accredited by MDSAP. The audit covers quality system requirements harmonized across all participating jurisdictions.
MDSAP Audit Grades
MDSAP uses a scoring system (1–5) for nonconformances. Grade 5 triggers regulatory action by participating authorities.
Key Differences at a Glance
| Feature | FDA Inspection | MDSAP Audit | |---|---|---| | Conducted by | FDA Investigator | Accredited AO | | Frequency | Risk-based (typically every 2 years) | Annual | | Jurisdictions covered | FDA only | Up to 5 regulators | | Health Canada acceptance | No | Yes (mandatory for Canadian market) | | Outcome document | Form 483 | MDSAP Audit Report |
Should You Pursue MDSAP?
MDSAP is mandatory if you want to sell devices in Canada — Health Canada requires it for all device licence holders. For U.S.-only manufacturers, MDSAP participation can reduce FDA inspection frequency as FDA uses MDSAP audit reports in place of routine surveillance inspections.
How United Regulatory Can Help
We prepare manufacturers for both FDA inspections and MDSAP audits: gap assessments, mock audits, 483 response drafting, and CAPA development. Reach out for a readiness assessment.