What 21 CFR Part 7 - Enforcement Policy: Recalls (Product Corrections), Health Hazard Evaluation, Recall Classification, and Industry Responsibilities requires
21 CFR Part 7 sets the FDA enforcement policy framework for recalls of FDA-regulated products and codifies the recall guidance for industry, health-hazard evaluation, recall classification, recall strategy, FDA-requested recall, firm-initiated recall, recall communications, public notification, recall status reports, and termination of a recall. Section 7.3 defines the operative terms: (g) recall as a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action (e.g., seizure); recall does not include a market withdrawal or a stock recovery; (h) correction as repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal; (j) market withdrawal as a firm's removal or correction involving a minor violation not subject to legal action or no violation (e.g., normal stock rotation); (k) stock recovery as a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm; (l) recall strategy as a planned specific course of action addressing depth of recall, public warnings, and extent of effectiveness checks; (m) recall classification as the numerical designation (Class I, II, or III) indicating relative degree of health hazard: Class I is a reasonable probability of serious adverse health consequences or death, Class II is temporary or medically reversible adverse health consequences (or remote serious consequences), Class III is unlikely to cause adverse health consequences. Section 7.40 establishes recall as a voluntary action taken by manufacturers and distributors to protect public health. Section 7.41 requires an ad hoc FDA scientist committee to evaluate the health hazard considering occurrences of disease or injuries, existing exposure conditions, hazard assessment to population segments (children, surgical patients, pets, livestock), seriousness, likelihood, and consequences (immediate or long-range). Section 7.42 sets recall strategy elements: depth of recall (consumer/user level, retail level, or wholesale level), public warning (reserved for urgent situations - general public warning, or targeted), effectiveness checks (A=100%, B=2-100%, C=10%, D=2%, E=none), and product disposition. Section 7.45 authorises FDA-requested recall where the product presents risk of illness or injury or gross consumer deception, the firm has not initiated a recall, and agency action is necessary. Section 7.46 governs firm-initiated recalls including the FDA notification within 24 hours and the information to be submitted. Section 7.49 prescribes recall communications (telegrams, mailgrams, first class letters marked 'drug [or food, biologic, etc.] recall [or correction]', and 'urgent' for Class I and II recalls). Section 7.50 publishes recalls in the weekly FDA Enforcement Report. Section 7.53 requires periodic recall status reports (typically every 2-4 weeks) including consignees notified, response rate, products returned or corrected, and effectiveness check results. Section 7.55 terminates a recall when reasonable efforts have been made and proper disposition or correction is complete.
Pillar: Medical & Healthcare · Authority: United States Food and Drug Administration, Department of Health and Human Services, implementing the Federal Food, Drug, and Cosmetic Act under 21 USC 321-393 and the Public Health Service Act under 42 USC 241, 262, 263b-263n, 264; published in the Code of Federal Regulations Title 21 Part 7; source 42 FR 15567, 22 March 1977 as subsequently amended · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7
SHA-256 integrity: b3312fd05ad35b0eabee1dfd46e1c150385a326f50e6b06fa69dc3b5a3bb96fe
Primary Citations — 11 traced to source
- 21 CFR 7.3 - Definitions - including recall (firm's removal or correction of a marketed product in violation against which FDA would initiate legal action e.g. seizure), correction (repair, modification, adjustment, relabeling, destruction, or inspection including patient monitoring without physical removal), recalling firm, market withdrawal (minor or no violation e.g. normal stock rotation), stock recovery (product not marketed or in direct firm control), recall strategy (planned course of action addressing depth of recall, public warnings, effectiveness checks), and recall classification (Class I reasonable probability of serious adverse health consequences or death, Class II temporary or medically reversible adverse health consequences or remote serious consequences, Class III unlikely to cause adverse health consequences)
- 21 CFR 7.40 - Recall policy - recall as an effective method of removing or correcting products in violation of laws administered by FDA, a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect public health and well-being
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