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Electronic Distribution of Product Information and Safety Communications

This guidance describes FDA's position on using electronic means (email, fax, text messaging) for distributing product information, including voluntary recall communications and important drug safety information. It applies to FDA-regulated products and clarifies that electronic communications are acceptable alternatives to traditional paper-based methods specified in 21 CFR §§ 7.49 and 200.5.

  1. Implement electronic communication systems with appropriate authentication and verification capabilities
  2. Establish procedures for tracking delivery and read receipts
  3. Create templates for electronic communications that follow formatting guidelines
  4. Develop follow-up procedures for unacknowledged communications
  5. Establish documentation system for tracking recall effectiveness
  6. Create clear protocols for emergency vs. non-emergency communications
  7. Train staff on proper electronic communication procedures
  8. Implement backup communication methods for cases where electronic delivery fails
  9. Establish procedures to verify recipient contact information
  10. Create system for maintaining records of all electronic communications

Key Considerations

Labelling

  • Communications should be brief and to the point
  • Must clearly identify the product with size, lot numbers, or other identifying information
  • Should not contain irrelevant qualifications or promotional materials

Software

  • Electronic communications systems should include authentication and verification programs
  • Should have capability for delivery or read receipt confirmation
  • Should include mechanisms for electronic receipt acknowledgement

Cybersecurity

  • Systems must ensure authenticity of sender identity
  • Should include safeguards against false information dissemination

Safety

  • Must explain concisely the reason for recall and hazard involved
  • Provide specific instructions on what should be done with recalled products
  • Communications should be distinctive in appearance for prompt recognition

Other considerations


Original guidance

  • Electronic Distribution of Product Information and Safety Communications
  • HTML
  • Issue date: 2006-02-28
  • Last changed date: 2024-08-09
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Food & Color Additives, Biologics, Cosmetics, Administrative / Procedural
  • ReguVirta summary file ID: 59ac7fa424daf8c90ba3f0d2007c1c8b
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