Description
The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use,content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance also discusses what information should be included in a public warning, as well as the parties responsible for issuing it. It represents FDA’s current thinking on public warning and notification of recalls under 21 CFR Part 7.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
7Products excluded from the scope of this specific guidance.
Example of a product where notification might be delayed to allow doctor consultation
Recalls associated with a high level of hazard requiring public warnings.
Recalls presenting a serious hazard to health but not rising to Class I.
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Early-phase randomized, double-blind, parallel assignment clinical study
Recalls due to potential particulate matter contamination.
Stakeholders
2The entity responsible for the removal or correction of a product.; The entity responsible for initiating the recall and developing the strategy.; The entity taking specific action to remove or correct a product
The party receiving the imported goods, responsible for submitting evidence.
Regulatory Context
Regulatory Activities
3Tattoo ink firms conducted voluntary ink recalls due to microbial contamination
Recalls required by the agency, listed in the Enforcement Report
Anticipated legal action under section 304 of the FD&C Act
Document Types
4public listing of products in the marketplace that are being recalled
Alert to the public regarding serious health hazards from recalled products.
Plan submitted to FDA for review and comment; Plan provided to FDA regarding recall execution
FDA manual containing procedures for removal from DWPE
Attributes
1The categorization of a recall in the FDA Enforcement Report
Identified Hazards
Hazards
6Criteria for issuing a public warning
Condition triggering the need for a public warning.
biological hazard in dried milk powder; Microbiological hazard in pet treats; hazard in animal-derived protein ingredients; biological hazard requiring control in turmeric
biological hazard in frozen ice cream novelty; Biological hazard in cheese
severe paralytic illness caused by C. botulinum toxin
Reason for Class II recalls involving food products.
Related CFR Sections (6)
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
- 21CFR7.41§ 7.41 Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being recalled or considered for recall will be conducted by an ad hoc committee of Food and Drug Administration scientists and will take into account, but need not be limited to, the following factors:Read full regulation →
- 21CFR7.42§ 7.42 Recall strategy.
(a) General.Read full regulation →
- 21CFR7.50§ 7.50 Public notification of recall.
The Food and Drug Administration will promptly make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall according to its classification, whether it was Food and Drug Administration-requested or firm-initiated, and the specific action being taken by tRead full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR20.91§ 20.91 Use of data or information for administrative or court enforcement action.
Nothing in this part or this chapter shall prevent the Food and Drug Administration from using any data or information, whether obtained voluntarily or involuntarily and whether or not it is available for public disclosure, as the basis for taking any administrative or court enforcement action withiRead full regulation →
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (Status: Final)
- Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)