Manufacturing Site Inspections and PMA Review Process for Medical Devices
This guidance explains the administrative process for reviewing manufacturing information and conducting inspections for Premarket Approval Applications (PMAs) and certain PMA supplements. It outlines the sequence of events, timelines, and procedures for FDA's review of manufacturing sections and facility inspections as part of the PMA approval process.
Recommended Actions
- Ensure manufacturing facility is ready for inspection at time of PMA filing
- Complete all process validations before inspection
- Successfully transfer design to production before inspection
- Have manufacturing process operational during inspection when possible
- Submit six copies of PMA or three copies of PMA supplement
- Respond promptly to any deficiency letters or real-time communications from FDA
- For foreign facilities, plan for additional time needed for inspection coordination
- Prepare for potential re-inspection if deficiencies are identified
- Maintain clear communication with FDA regarding facility readiness status
- Document and implement corrections for any identified deficiencies promptly
Key Considerations
Other considerations
- Manufacturing facilities must be ready for inspection at the time of PMA filing unless stated otherwise
- All process validations should be completed and design successfully transferred to production before inspection
- Manufacturing process should preferably be in operation during inspection
- Review timelines:
- Non-expedited Traditional PMA: 30 calendar days
- Expedited Traditional PMA: 20 calendar days
- Domestic inspections: 45 calendar days after assignment
- Foreign inspections: 60 calendar days after assignment
- Inspection outcomes can be:
- Quality System Information Requirements for Premarket Submissions
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Related references and norms
- 21 CFR 820: Quality System Regulation
- 21 CFR 814.20(b)(2): PMA submission requirements
- 21 CFR 814.39: PMA supplements requirements
Original guidance
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