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Civil Penalties for Electronic Product Radiation Control Violations

This guidance outlines the FDA's policy for assessing civil penalties against manufacturers and importers of electronic products under the Electronic Product Radiation Control provisions of the FFDCA. It specifically details when the Agency will recommend civil penalties, with or without prior warning, for violations related to electronic product radiation control.

  1. Establish a robust quality system to ensure compliance with performance standards
  2. Implement a comprehensive record-keeping system for product distribution
  3. Develop procedures for prompt FDA notification of product defects
  4. Create a process for timely implementation of corrective actions
  5. Establish procedures for proper certification of products
  6. Maintain complete and accurate records for FDA inspection
  7. Create a system for tracking and responding to FDA communications
  8. Develop procedures for notifying purchasers when required
  9. Train staff on compliance requirements and violation reporting
  10. Implement a monitoring system to prevent recurring violations

Key Considerations

Labelling

  • Labels must be permanently affixed to products

Safety

  • Manufacturers must notify FDA upon discovery of product defects
  • Products must comply with applicable performance standards
  • Manufacturers must implement corrective actions when notified by CDRH
  • Manufacturers must notify purchasers when required

Other considerations

  • 21 CFR 17.2: Civil Money Penalties Hearings

Original guidance

  • Civil Penalties for Electronic Product Radiation Control Violations
  • HTML
  • Issue date: 2005-04-01
  • Last changed date: 2018-12-01
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Administrative / Procedural, Investigation & Enforcement
  • ReguVirta summary file ID: 2b156c2635ddbad9f45c28d6d4d545b4
This post is licensed under CC BY 4.0 by the author.