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Overview
Definitions
Voluntary Recalls - 21 CFR 7
Mandatory Device Recalls - 21 CFR 810
Corrections and Removals - 21 CFR 806
Regulations
Federal Register Notices
A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).
Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.
Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.
Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.
Recall means 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.
Recall strategy means a planned course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.
Recalling firm means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled.
Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
Risk to health means (1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or (2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.
Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.
Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use.
A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
A recall is an alternative to an FDA-initiated court action for removing or correcting violative products that have been distributed. 21 CFR 7 sets forth specific recall procedures for FDA to monitor recalls and assess the adequacy of a firm's efforts in recall. Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the FDA. A request by the FDA that a firm recall a product is reserved for urgent situations and is directed to the firm that has primary responsibility for the manufacture and marketing of the product that is to be recalled.
Recall does not include market withdrawal or a stock recovery. A market withdrawal is a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. Almost all recalls are conducted on a voluntary basis by the manufacturer.
Please note an electronic product that emits radiation and is subject to 21 CFR 1003 and 1004 is not subject to the requirements under 21 CFR 7.
An evaluation of the health hazard presented by a product being recalled or considered for recall is conducted by FDA and takes into account, but need not be limited to, the following factors:
On the basis of this determination, the FDA will assign the recall a classification, i.e., Class I, Class II, or Class III, to indicate the relative degree of health hazard of the product being recalled or considered for recall.
Recalls are classified into a numerical designation (I, II, or III) by the FDA to indicate the relative degree of health hazard presented by the product being recalled.
The recalling firm should develop a recall strategy that takes into account the following factors as they apply to the individual circumstances of the particular recall:
The FDA will review the adequacy of a proposed recall strategy and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy.
A recall strategy will address the following elements regarding the conduct of the recall:
The recalling firm will ordinarily be responsible for conducting effectiveness checks, but FDA will assist in this task where necessary and appropriate. The recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted, as follows:
A firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate FDA District Office. Such removal or correction will be considered a recall only if the FDA regards the product as involving a violation that is subject to legal action, e.g., seizure. In such cases, the firm will be asked to provide the FDA the following information:
The FDA will review the information submitted, advise the firm of the assigned recall classification, recommend any appropriate changes in the firm's strategy for the recall, and advise the firm that its recall will be placed in the weekly FDA Enforcement Report. Pending this review, the firm need not delay initiation of its product removal or correction.
A firm may decide to recall a product when informed by the FDA that the agency has determined that the product in question violates the law, but the agency has not specifically requested a recall. A firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with the appropriate FDA district office if the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e.g., because of complaints or adverse reactions regarding the product, that the product is deficient in some respect. In such cases, the FDA will assist the firm in determining the exact nature of the problem.
A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey:
A recall communication can be accomplished by telegrams, mailgrams, or first class letters conspicuously marked, preferably in bold red type, on the letter and the envelope: ``medical device recall [or correction]''. The letter and the envelope should be also marked: ``urgent'' for class I and class II recalls and, when appropriate, for class III recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the above methods and/or documented in an appropriate manner.
A recall communication should be written in accordance with the following guidelines:
The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication. It is highly recommended that the recalling firm discuss the recall letter with the FDA district office recall coordinator prior to issuing the notification.
Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with the instructions described above.
The recalling firm is requested to submit periodic recall status reports to the appropriate FDA district office so that the agency may assess the progress of the recall. The frequency of such reports will be determined by the relative urgency of the recall and will be specified by the FDA in each recall case; generally the reporting interval will be between 2 and 4 weeks. Unless otherwise specified or inappropriate in a given recall case, the recall status report should contain the following information:
Recall status reports are to be discontinued when the recall is terminated by FDA.
A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product. Written notification that a recall is terminated will be issued by the appropriate FDA district office to the recalling firm. A recalling firm may request termination of its recall by submitting a written request to the appropriate FDA district office stating that the recall is effective in accordance with the criteria set forth, and by accompanying the request with the most current recall status report and a description of the disposition of the recalled product.
FDA publishes a weekly FDA Enforcement Report that contains all enforcement actions including recalls, field corrections, seizures, and injunctions.
A recall can be disruptive of a firm's operation and business, but there are several steps a firm can take in advance to minimize this disruptive effect. Notwithstanding similar requirements under the Quality System regulation (21 CFR 820), the firm should take into consideration:
Having these procedures in place prior to the initiation of any recall will allow the recall process to proceed in an efficient manner.
Additional information documents on recalls are available:
Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).
If, after providing the appropriate person with an opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the FDA may issue a cease distribution and notification order requiring the person named in the order to immediately:
The person named in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that the order be modified, vacated, or amended. FDA may later amend the order to require a recall of the device.
Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health. A report must be made even if the event was caused by user error. A report is not required if the information has already been provided to FDA under Medical Device Reporting (21 CFR 803) or Repurchase, Repairs or Replacement of Electronic Products (21 CFR 1004) or if the corrective or removal action was initiated by an FDA order under Medical Device Recall Authority (21 CFR 810).
Manufacturers and importers must keep records of those corrections and removals that are not required to be reported to FDA. However, if a report is not required under 21 CFR 806, the firm may voluntarily report under 21 CFR 7.
The definition of ``risk to health'' under 21 CFR 806 tracks the definitions of class I and class II recall in 21 CFR 7.3(m). Therefore, reports of corrections and removals are required for class I and class II recalls. Under 21 CFR 806, manufacturers and importers need not report events categorized as class III recalls under 21 CFR §7; only record keeping requirements would apply.
The following actions are exempt from the reporting requirements:
Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device,
Manufacturers and importers are required to report a correction or removal of a product if it involves a risk to health. Only the person that initiates the correction or removal is required to report.
The report must be submitted to FDA within 10 working days from the time the firm initiates the recall. If there is not a "risk to health" involved, a report to FDA is not required, but the manufacturer or importer must keep a record of the recall.
Reports should be made to the FDA District Office in which the reporting facility is geographically located. Importers should contact the FDA District Office that covers their main port of entry.
If, after submitting a report, a manufacturer or importer determines that the same correction or removal should be extended to additional lots or batches of the same device, the manufacturer or importer must amend the original report by submitting an amendment within 10-working days of initiating the extension of the correction or removal [21 CFR 806.10(d)]. The amendment should cite the original report number assigned, all of the information required by 21 CFR 806.10(c)(2), and any information required by 21 CFR 806.10(c)(3) through (c)(12) that is different from the information submitted in the original report. The manufacturer or importer must also state what required information is not readily available and a date for when it will be submitted.
The device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA must maintain records of the correction or removal. Records must contain the following information:
The manufacturer or importer must retain all records for a period of two years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.
21
CFR 7 – Enforcement Policy
21
CFR 810 – Medical Device Recall Authority
21
CFR 806 – Medical Device Correction and Removals
Note: The Federal Register (FR) is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations, as well as executive orders and other presidential documents. In order to create or revise an existing regulation, FDA will publish a proposed rule in the FR and request comments. FDA will then evaluate all comments received and publish a final rule. Once a proposed rule is finalized, it is published in the Code of Federal Regulations (CFR).
Enforcement Policy: Recalls (Including Product Corrections) - Guidelines on Policy, Procedures, and Industry Responsibilities, June 16, 1978. Revised March 22, 1977, June 16, 1978, March 6, 1979, January 27, 1981, March 28, 1994, and September, 19, 2000
Updated July 30, 2007
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