Uniform Inspection Process and Communications for Medical Device Establishments
This guidance outlines FDA's uniform processes and standards for device establishment inspections (excluding for-cause inspections) of both foreign and domestic facilities. It specifically addresses pre-announcement procedures, inspection timeframes, and communication standards during inspections.
Recommended Actions
- Establish internal procedures for receiving and managing FDA inspection pre-announcements
- Develop a protocol for managing inspection communications and documentation
- Create a checklist for inspection preparation based on standard timeframes
- Train relevant staff on the inspection process and communication requirements
- Implement a system to track and document all inspection-related communications
- Prepare templates for recording daily inspection observations and discussions
- Establish procedures for handling potential inspection timeframe extensions
- Create a process for managing and responding to requests for advance records review
Key Considerations
Other considerations
- Pre-announcement of inspections required:
- Domestic inspections: minimum 5 calendar days notice
- Foreign inspections: more than 5 calendar days notice
- Standard inspection timeframe: 3-6 continuous business days
- Regular communication requirements during inspection:
- Daily discussions of observations when possible
- Verbal communication of inspection status
- Recording of communications allowed with mutual consent
- Pre-announcement should include:
- No specific norms or ISO standards referenced in this guidance
Original guidance
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