Public Warning and Notification of Recalls Under Part 7
This guidance provides recommendations for industry and FDA staff regarding public warnings and notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C. It applies to voluntary recalls of FDA-regulated products including food, drugs, devices, cosmetics, biologics, and tobacco products, but excludes radiation-emitting electronic products.
Recommended Actions
- Develop a recall strategy that includes criteria for issuing public warnings
- Create templates for public warnings that include all required information
- Establish processes to issue public warnings within 24 hours when requested by FDA
- Set up distribution channels for public warnings matching product distribution
- Monitor media coverage of issued warnings and take additional actions if coverage is insufficient
- Maintain documentation of all recall communications and public warnings
- Ensure public warnings remain accessible until product is no longer expected to be used
- Consider translation needs based on product user demographics
- Establish process to verify receipt of recall communications by business accounts
- Monitor FDA Enforcement Report for accuracy of recall information
Key Considerations
Safety
- Public warnings are required for urgent situations where products present serious health hazards
- Class I recalls generally require public warnings unless specific circumstances indicate otherwise
- Some urgent Class II recalls may require public warnings if presenting serious health hazards
- Public warnings should be issued within 24 hours of FDA notification
- The warning must include product identification, geographic distribution, defect description, health hazard details, and contact information
Other considerations
- Firms should develop their own recall strategy including public warning plans
- FDA may issue its own warning if a firm’s warning is deficient or not issued
- Public warnings should be distributed to match product distribution (regional/national)
- Translations may be needed for non-English speaking populations
- All recalls will be listed in the FDA Enforcement Report regardless of hazard level
Relevant Guidances
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
Related references and norms
- 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities
- 21 CFR Part 1240: Control of Communicable Diseases
Original guidance
- Public Warning and Notification of Recalls Under Part 7
- HTML / PDF
- Issue date: 2019-02-08
- Last changed date: 2023-09-29
- Status: FINAL
- Official FDA topics: Tobacco, Medical Devices, Food & Beverages, Investigation & Enforcement, Drugs, Animal & Veterinary, Biologics, Recalls
- ReguVirta summary file ID: 8103994b53d6ad78251bf4cc68723816
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