Electronic Distribution of Product Information and Safety Communications

What You Need to Know? 👇

What electronic methods can be used for medical device recall communications?

The FDA allows email, fax, text messaging, and other electronic communications for recall notifications. These methods must effectively convey necessary information to recipients and accomplish the same objective as traditional delivery methods like mail or telegrams.

Are there specific formatting requirements for electronic recall communications?

No specific format is required for electronic communications. However, emails should include “URGENT” in subject lines for appropriate recalls, be distinctive in appearance, and follow feasible specifications from existing regulations to ensure prompt recognition and reading.

How can manufacturers verify receipt of electronic safety communications?

Electronic communications can use delivery receipts, read receipt confirmations, or other electronic acknowledgment mechanisms. If receipt isn’t confirmed appropriately, senders should resort to traditional notification methods to ensure the communication reaches its intended recipient.

What advantages do electronic communications offer over traditional mail for safety information?

Electronic communications significantly reduce time between safety events and public notification, are more cost-effective than traditional delivery services, can be automatically verified for receipt, and allow for rapid electronic follow-up when needed.

Does FDA’s Part 11 regulation apply to electronic recall communications?

Part 11 regulations apply only to records required under FDA regulations and maintained electronically. For voluntary recall communications not subject to underlying record-keeping regulations, Part 11 would typically not apply to these electronic communications.

Can healthcare providers receive important drug safety information electronically?

Yes, manufacturers and distributors may use email or other electronic methods to send important drug safety information to healthcare providers. This is particularly effective when providers voluntarily provide electronic addresses, bypassing spam filters and gatekeepers.

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What You Need to Do 👇

Recommended Actions

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

• 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

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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

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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 ID: 59ac7fa424daf8c90ba3f0d2007c1c8b