Remote Regulatory Assessments for FDA-Regulated Products and Establishments (DRAFT)

This is a draft guidance. Not for implementation.

Recommended Actions

1. Establish internal procedures for responding to RRA requests (both mandatory and voluntary)
2. Ensure technological capabilities are in place to support remote assessments including:
   • Video streaming capabilities
   • Secure file sharing systems
   • Screen sharing capabilities
   • Adequate internet connectivity
3. Prepare documentation systems to enable quick response to records requests:
   • Implement searchable electronic documentation when possible
   • Establish process for scanning paper records
   • Maintain translation capabilities if needed
4. Train relevant personnel on:
   • RRA response procedures
   • Technology tools used for remote assessments
   • Documentation requirements
   • Communication protocols with FDA during RRAs
5. Establish process for:
   • Reviewing RRA observations
   • Developing responses within 15-day timeframe
   • Implementing and documenting corrective actions
6. Create contingency plans for:
   • Technology failures during remote assessments
   • Handling confidential information
   • Managing resource constraints during RRAs

Key Considerations

Clinical testing

• Records or data related to the reporting or conduct of FDA-regulated research may be requested for establishments subject to BIMO inspection

Software

• Electronic systems may be reviewed through screen sharing and livestream/video
• Read-only access to electronic databases may be requested
• Establishments should identify any limitations on external access and ensure encrypted/password-protected files can be accessed by FDA

Cybersecurity

• Quality of remote connection should be adequate for FDA review
• FDA will provide secure means to send requested records
• Technologies should have appropriate security and privacy controls

Other considerations

• Records should be submitted in electronic format when possible
• Paper records should be scanned as searchable PDFs when possible
• Records may need to be provided in English or with English translation
• FDA may request records within reasonable timeframes based on establishment size, complexity of records, and urgency
• Establishments should respond to observations within 15 U.S. business days
• RRAs do not replace FDA inspections but can complement them

  Relevant Guidances

• Content of Premarket Submissions for Device Software Functions
• Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
• Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
• Electronic Records and Electronic Signatures - Scope and Application

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Original guidance

• Remote Regulatory Assessments for FDA-Regulated Products and Establishments
• HTML / PDF
• Issue date: 2024-02-02
• Last changed date: 2024-11-05
• Status: DRAFT
• Official FDA topics: Tobacco, Inspection, Medical Devices, Food & Beverages, Dietary Supplements, Investigation & Enforcement, Regulation, Electronic Submissions, Drugs, Import, Animal & Veterinary, Compliance, Biologics, Records, Cosmetics, Administration
• ReguVirta summary file ID: e7b0e5c924ac353b676f53364d7d3200