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.
Recommended Actions
- Implement electronic communication systems with appropriate authentication and verification capabilities
- Establish procedures for tracking delivery and read receipts
- Create templates for electronic communications that follow formatting guidelines
- Develop follow-up procedures for unacknowledged communications
- Establish documentation system for tracking recall effectiveness
- Create clear protocols for emergency vs. non-emergency communications
- Train staff on proper electronic communication procedures
- Implement backup communication methods for cases where electronic delivery fails
- Establish procedures to verify recipient contact information
- 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
- Electronic communications should reach the appropriate level in the distribution chain
- Follow-up communications should be sent to those who fail to respond
- Documentation of recall communications and effectiveness should be maintained
- Subject lines should include signal of importance and product name
- Communications should be concise and clear about consequences if information is not followed
Relevant Guidances
- Electronic Records and Electronic Signatures - Scope and Application
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Postmarket Management of Cybersecurity in Medical Devices
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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