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.
What You Need to Know? 👇
What is the minimum advance notice required for FDA device establishment inspections?
For domestic inspections, FDA provides at least five calendar days advance notice. Foreign inspections typically receive more than five days notice due to country clearance requirements. The pre-announcement includes inspection type and nature information.
How long do FDA device establishment inspections typically last?
FDA inspections generally range from 3 to 6 continuous business days, depending on whether it’s an abbreviated or comprehensive surveillance inspection, or a pre-approval inspection. Duration may extend based on operational complexity and deficiencies found.
Can FDA still conduct unannounced inspections of medical device facilities?
Yes, FDA retains full authority to conduct unannounced, for-cause inspections. The uniform processes and standards described in this guidance apply only to routine inspections conducted according to risk-based schedules, not for-cause inspections.
What communication standards must FDA follow during device establishment inspections?
Investigators must maintain regular verbal communication with facility management about inspection status. When possible, observations should be discussed as they occur or daily to minimize misunderstandings. Communications may be recorded with advance notice and mutual consent.
What information does FDA provide during pre-announcement of device inspections?
FDA provides information about the inspection type and nature (surveillance or pre-approval), planned timeframe and duration, appropriate working hours, and advance notice of some records that may be requested during the inspection, such as procedures and associated records.
Can device establishment inspection timeframes be extended beyond the standard duration?
Yes, inspections may be extended for various reasons including complex operations, staff availability issues, observed deficiencies, or follow-up on post-market safety information like recalls and Medical Device Reports. Extensions should be communicated verbally during the inspection.
What You Need to Do 👇
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:
- Type and nature of inspection
- Planned timeframe and duration
- Advance notice of records that may be requested
Related references and norms 📂
- No specific norms or ISO standards referenced in this guidance