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General regulatory information for laboratory, clinic and supply staff. It is not legal advice or medical advice. For a specific recall notice, follow the instructions in that notice.
Short answer
21 CFR Part 7, Subpart C is the part of the US federal regulations that sets out how FDA treats recalls: what counts as a recall, how FDA classifies the health hazard, how a recall strategy is built, what a recall notice should contain, and how a recall ends. It covers all FDA-regulated products, including medical devices. Its recall provisions are guidance that recognises recall as voluntary; it works alongside 21 CFR 806 (reports of corrections and removals) and 21 CFR 810 (mandatory device recall orders).
Definition and scope
Section 7.3(g) defines a recall as a firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, for example seizure. Section 7.40 describes recall as a voluntary action that firms take to protect public health, and as an alternative to FDA-initiated court action. Sections 7.40 through 7.59 give the framework; they do not make a firm’s choice to act mandatory.
Two terms in 7.3 matter for anyone who receives a notice. A correction (7.3(h)) is repair, modification, adjustment, relabeling, destruction or inspection of a product without its physical removal to some other location. A consignee (7.3(n)) is anyone who received, purchased or used the recalled product, so a lab or clinic that bought a recalled item is a consignee even if it is not the manufacturer’s direct account.
21 CFR 7 recalls for medical devices: Part 7, Part 806 and Part 810
Three parts of Title 21 are often confused. Part 7 defines recalls and how FDA classifies and monitors them. Part 806 requires a device firm to report certain corrections and removals to FDA within 10 working days of initiating the action, and to keep records of ones it does not report (see 21 CFR Part 806). Part 810 is a separate proceeding under which FDA can order a device recall; it is not a step up from a Part 7 recall. A single field action can therefore be a Part 806 report without being a Part 7 recall, because Part 7 only counts actions against violative products. For a plain-language overview of device recalls, see medical device recall.
Recall, market withdrawal and stock recovery
Part 7 draws a line that decides whether an action is a recall at all.
| Term (7.3) | What it covers | Is it a recall? |
|---|---|---|
| Recall (7.3(g)) | Removal or correction of a marketed product FDA considers violative and would take legal action against | Yes |
| Market withdrawal (7.3(j)) | Removal or correction of a distributed product involving a minor violation FDA would not act on, or no violation, for example normal stock rotation or routine equipment adjustments | No |
| Stock recovery (7.3(k)) | Removal or correction of a product that has not been marketed or has not left the firm’s direct control | No |
Recall classes under 7.3(m)
FDA, not the firm, assigns the class after a health hazard evaluation. Class I is a reasonable probability that using or being exposed to the violative product will cause serious adverse health consequences or death. Class II is a situation where use may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. Class III is a situation where use is not likely to cause adverse health consequences. Section 7.41 lists the factors in the hazard evaluation, including whether injuries have already occurred, which groups are at risk, and the seriousness and likelihood of the hazard. For the Class III case, see Class 3 recall; for a side-by-side view, see Class I vs II vs III.
How a Part 7 recall runs, step by step
| Stage | Section | What the text provides |
|---|---|---|
| Start | 7.45, 7.46 | A firm may remove or correct a product on its own and is asked to notify FDA at once if it believes the product is violative; FDA may also request a recall when a distributed product presents a risk, the firm has not acted and agency action is needed |
| Information to FDA | 7.46(a) | Product identity, reason, discovery circumstances, risk evaluation, quantity produced and in distribution, distribution data, a copy of the recall communication, proposed strategy and a contact person |
| Classification | 7.41, 7.46(b) | FDA assigns Class I, II or III and tells the firm the recall will appear in the weekly FDA Enforcement Report |
| Strategy | 7.42 | Depth of recall, public warning and effectiveness checks, shaped by hazard, ease of identifying the product, how obvious the defect is and how much product is unused |
| Notice to accounts | 7.49 | The firm promptly notifies each affected direct account |
| Progress | 7.53 | Periodic status reports to FDA, generally at 2 to 4 week intervals |
| End | 7.55 | FDA terminates the recall and the district office sends the firm written notice |
FDA lists each new recall by class in the weekly Enforcement Report (7.46(b)); see FDA Enforcement Reports for how to search it, and FDA recall coordinator for the firm-side contact role.
Where it matters for labs, clinics and supply decisions
Section 7.49(c) says a recall communication should identify the product, size, lot numbers, codes or serial numbers, explain the reason and any hazard, give specific instructions on what to do with the product, and give the recipient a ready way to tell the firm whether it holds any. Section 7.49(a) says the communication conveys that the product is recalled, that further distribution or use of remaining product should cease immediately, and, where appropriate, that the account should notify its own customers. Section 7.49(d) says consignees should immediately carry out the instructions. Read together, these give a checklist for the person who opens a notice:
- Does the notice identify the exact product, size, lot or serial numbers, so you can match them to what you hold?
- Does it state the reason and the hazard?
- Does it give instructions for the recalled product and say whether use must stop now?
- Does it ask whether you pass the product on to others, in which case you may need to notify them?
- Does it give a way to report back to the firm whether you hold the product?
The firm’s own corrective action process is a separate subject; see CAPA and FDA.
Common misunderstandings
- A recall means everything is physically removed. Under 7.3(g) a recall is a removal or a correction, and 7.3(h) corrections happen without moving the product.
- Every removal is a recall. Market withdrawals and stock recoveries are expressly outside the definition.
- The firm chooses the class. FDA assigns it under 7.41(b) and 7.46(b).
- Part 7 and Part 806 are the same obligation. They differ in trigger, purpose and who receives the report.
- Class III needs no attention. Class III is still a recall under 7.3(m), even though use of the product is not likely to cause adverse health consequences.
FAQ
What is 21 CFR 7?
Part 7 of Title 21 covers FDA enforcement policy. Its Subpart C (7.40 to 7.59) is the recall framework: policy, hazard evaluation and classification, strategy, communications, status reports and termination.
What does 21 CFR 7 say about recalls of medical devices?
It applies to devices the same way as to other FDA-regulated products: a device correction or removal is a recall when FDA considers the device violative and would take legal action. The device-specific report requirements are in Part 806 and the order authority is in Part 810.
Are recalls under Part 7 voluntary?
Section 7.40 describes recall as a voluntary action. FDA can request a recall under 7.45, but a device recall order is a separate proceeding under Part 810.
Who ends a recall?
FDA does, under 7.55, when it determines that all reasonable efforts have been made to remove or correct the product; the firm can request termination in writing and FDA’s district office issues the written notice.
