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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.

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By ReguVirta
3 min read

What You Need to Know? 👇

What triggers the need for a public warning during a medical device recall?

Public warnings are required for urgent situations where medical devices present serious health hazards and other communication methods appear inadequate. This includes home-use devices that could malfunction causing incorrect dosing, implantable devices with sudden battery failure risks, or when devices are widely distributed to consumers who cannot be directly contacted.

How quickly must companies issue public warnings after FDA notification?

Companies should generally issue public warnings within 24 hours of FDA notification that a warning is appropriate. The specific timeframe may vary depending on the recall circumstances and product type, but prompt action is essential to protect public health and prevent continued use of hazardous products.

What essential information must be included in a medical device recall public warning?

Public warnings must include product identification details (UDI numbers, serial numbers, lot numbers), distribution areas and dates, thorough defect description, health hazard explanation, company contact information, consumer instructions, associated illness/injury reports, and symptom descriptions. Headlines should clearly state the product and hazard.

Can FDA issue its own public warning if a company refuses or provides inadequate warning?

Yes, FDA may prepare and issue public warnings independently when companies refuse to issue warnings, provide deficient warnings, or when immediate public notification is needed. FDA will generally work with firms for factual accuracy but is not required to allow company review before issuing warnings.

What makes a medical device recall public warning considered deficient by FDA?

Warnings are deficient if they inadequately identify the recalled product, fail to describe health hazards properly, lack distribution information, don’t reach target audiences effectively, contain unverifiable facts, or include promotional content that detracts from the safety message. Phrases like “abundance of caution” should be avoided.

How are medical device recalls listed in the FDA Enforcement Report different from public warnings?

The FDA Enforcement Report provides public listings of all recalls regardless of hazard level and is not limited to urgent situations. Public warnings are specifically for serious health hazards requiring immediate public alert. All recalls appear in the Enforcement Report, but only urgent situations warrant public warnings.

What You Need to Do 👇

  1. Develop a recall strategy that includes criteria for issuing public warnings
  2. Create templates for public warnings that include all required information
  3. Establish processes to issue public warnings within 24 hours when requested by FDA
  4. Set up distribution channels for public warnings matching product distribution
  5. Monitor media coverage of issued warnings and take additional actions if coverage is insufficient
  6. Maintain documentation of all recall communications and public warnings
  7. Ensure public warnings remain accessible until product is no longer expected to be used
  8. Consider translation needs based on product user demographics
  9. Establish process to verify receipt of recall communications by business accounts
  10. 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 đź”—

Related references and norms đź“‚

  • 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 ID: 8103994b53d6ad78251bf4cc68723816
FDA guidance, Final
Tobacco Medical Devices Food & Beverages Investigation & Enforcement Drugs Animal & Veterinary Biologics Recalls
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