An MD&DI September 1997 Column
Regulation ties the risk-to-health standard to existing Class I and II definitions.
On May 19, 1997, FDA published its final rule for implementing the reports of corrections and removals provision of the Safe Medical Devices Act of 1990 (SMDA).1 Medical device manufacturers, importers, and distributors must now submit a written report to FDA within 10 days of a correction or removal of a device that was initiated to reduce a risk to health. This means that device manufacturers must draft new standard operating procedures (SOPs) that distinguish between reportable and nonreportable events and implement employee training in the new procedures. Moreover, although FDA has worked to narrow the term risk to health to include only the more serious risks, each company must still struggle with the question of which events are trivial and which must be reported. Drafting clear SOPs, initiating appropriate employee training programs, and maintaining relations with local recall coordinators will be key to smoothly integrating the new requirements.
The SMDA required FDA to promulgate a regulation requiring all manufacturers, importers, or distributors of a device to report promptly to FDA any correction or removal of a device undertaken to reduce a health risk posed by the product or to remedy a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) caused by the device that may present a health risk.2 Congress believed that the device industry was not reporting recalls to FDA, thus denying the agency the opportunity to fulfill its public health responsibilities by evaluating device-related problems and the adequacy of corrective actions.3
Before the SMDA, there was no specific legal requirement to report recalls or other remedial actions in the field to FDA. Nevertheless, companies have commonly advised the agency of such actions under the voluntary recall guidelines set forth in 21 CFR Part 7. Even if a field action does not require reporting under the new regulation, a company can still report it under these voluntary guidelines.
In Part 7, FDA outlines how its regulated industries, including the device industry, should handle voluntary recalls, market withdrawals, and stock recoveries. In the past, when FDA learned of a recall, it classified the recall into one of three categories:
- Class I: Those situations in which there is a reasonable probability that use of, or exposure to, a product will cause serious adverse health consequences or death.
- Class II: Those situations in which use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences or when the probability of serious adverse health consequence is remote.
- Class III: Those situations in which use of, or exposure to, a product is not likely to cause adverse health consequences.
Under standard industry practice in the past, most medical device manufacturers reported Class I or serious Class II recalls to the recall coordinator in the appropriate FDA district office. That office, working with the Center for Devices and Radiological Health (CDRH), would classify the recall and work with the company to assure that the recall was carried out properly and that the appropriate effectiveness checks were completed. Admittedly, some Class III recalls were simply documented in the companies' files without directly notifying the agency. Some companies did not want the adverse publicity that could arise from a voluntary recall report to FDA.
When voluntary recalls under Part 7 are reported to the agency, the information regarding the recall is included in the FDA Weekly Enforcement Report. Similarly, upon learning of a recall through an inspection or other means, FDA also typically documents it in the enforcement report, sometimes months or even years after the recall. Whether publicity about a recall will actually harm a company depends, of course, on the scope and nature of the recall, but many companies have been disinclined to report recalls.
The corrections and removals reporting regulation is meant to standardize the reporting of recalls and provide FDA with information on corrective actions for products that may present a risk to health. Industry, at the time this provision was passed by Congress, was concerned that FDA would interpret risk to health so broadly that almost any type of corrective action, including trivial ones, would need to be reported. FDA has been sensitive to that concern, and the final regulation requires reporting of only the more serious risks to health.
The new regulation is extremely important to the 20,000 manufacturers, importers, and distributors of medical devices subject to its provisions. Every company covered by this regulation must draft new SOPs for corrections and removals reporting. Failure to comply with the regulation can lead to FDA enforcement action, including seizure, injunctive action, civil penalties proceedings, or even potential criminal prosecution.
Who Must Report, and When. Under the new regulation, a written report must be submitted to FDA for any correction or removal of a device initiated either to reduce a risk to health or to remedy a violation of the FD&C Act. A correction means any repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location. Removal is defined as the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
If the information required by the new regulation has already been provided to the agency through a medical device report (MDR, 21 CFR 803) or a distributor report (21 CFR 804), or under the reporting requirements for electronic products (21 CFR 1004), then an additional report does not need to be filed. Similarly, corrective actions or removals under the mandatory recall provisions of section 518(e) of the FD&C Act do not need to be reported. That section authorizes FDA to initiate mandatory recall actions if there is a reasonable probability that the device could cause serious adverse health consequences or death.
FDA expects little overlap between MDR requirements and the new regulation; it says MDR reports focus on the adverse event and not on field remedial actions. The agency does recognize, however, that there will be some overlap with MDR five-day reports because under 21 CFR 803.44, an event must be reported if it requires remedial action to prevent substantial harm to the public health. If reported under the MDR regulation, these events and the corrective action do not need to be reported again.
The reporting burden falls equally on distributors, importers, and manufacturers. Under the final regulation, the term manufacturer includes any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures. The term also includes repackagers, those who initiate specifications for devices that are manufactured for a second party, and manufacturers of components or accessories that are devices ready to be used, intended to be commercially distributed, and intended to be used as is, or processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.
Distributor is more narrowly defined and includes only those who further the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user but who does not repackage or change the container, wrapper, or labeling of the device or device package. The term includes importers. This definition is essentially the same as that contained in the distributor reporting regulation.
The reporting party must submit its report to the appropriate FDA district office within 10 working days of initiating the correction or removal. Also, foreign manufacturers or owner-operators of devices are required to submit reports within this time frame.
As noted, only corrections or removals that present a risk to health need be reported. Risk to health is defined as a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; temporary or medically reversible adverse health consequences; or an outcome in which the probability of serious adverse health consequences is remote. This definition is perhaps the key provision in the regulation. Many commenters on the original March 23, 1994, proposed rule thought the definition of risk to health was too broad.4 FDA agreed. In narrowing the definition, FDA stated that the practical effect of the revised definition will be to require reports only for corrections classified as Class I or Class II recalls under the voluntary recall regulations.5 FDA also indicated that the term serious adverse health consequences was intended to mean the same thing as the term serious injury in the MDR rule. Serious injury was defined as an illness or injury that is either life-threatening, results in permanent impairment of a body function or permanent damage to body structure, or requires medical or surgical intervention to preclude permanent damage to a body structure (21 CFR 803.3(h)).
The key issue for companies drafting SOPs for the new regulation is to define risk to health. FDA stated in the preamble that the revised definition should preclude making companies file reports for extremely remote, trivial risks to the public health. Figuring out what is trivial, however, may not always be easy. Companies have struggled for years to decide whether a recall should be categorized as Class II (now reportable) or Class III (not reportable).
FDA has also made it clear that companies are not required to report market withdrawals and stock recoveries. Market withdrawal is a correction or removal of a distributed device that involves a minor or no violation of the FD&C Act, such as, for example, normal stock rotation practices. This definition is essentially the same as that in the voluntary recall guidelines at Part 7 (21 CFR 7.3(j)) and requires the company to decide whether the correction or removal is so minor that FDA would not consider it appropriate for legal action.
Similarly, stock recoveries are defined as corrections or removals of a device that has not been marketed or that has not left the direct control of the manufacturer; that is, the device is located on premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the correction or removal has been released for sale or use. Again, this definition is essentially the same as that in the voluntary guidelines at Part 7 (21 CFR 7.3(k)). A stock recovery would not normally be carried out to reduce a risk to health or to remedy a violation of the FD&C Act and thus would not be reportable. Nevertheless, there may be times when companies must decide if an action is a nonreportable stock recovery or market withdrawal or a reportable correction or removal. Industry has often had difficulty classifying field actions as market withdrawals, stock recoveries, or recalls, and that difficulty is likely to continue.
Finally, routine servicing need not be reported. Routine servicing is any regularly scheduled maintenance, including the replacement of parts at the end of their normal life expectancy, for example, calibration, replacement of batteries, and responses to normal wear and tear. Unexpected repairs, replacement of parts before the end of their normal life expectancy, or identical repairs or replacements of multiple units of a device are not considered routine, and may, under certain unusual circumstances, need to be reported to FDA. To help companies decide whether an event is reportable, the new SOPs should probably include examples distinguishing between routine service and events such as unexpected replacement of a battery in an automatic external defibrillator due to early depletion.
What to Do if Correction or Removal Is Nonreportable. Under 21 CFR 806.20, companies are directed to keep a record of corrections or removals that are nonreportable. They must keep in their files the product's brand name, model catalog or code number, including lot or serial number, and a description of the events giving rise to the nonreportable correction or removal action. Companies are also required to keep a justification for not reporting the correction or removal to FDA, including conclusions and any follow-ups. The decision not to file must be reviewed and evaluated by the designated entity within the corporation. Copies of all communications regarding the correction or removal must also be kept. Finally, these records must be maintained for FDA inspection for a period of two years beyond the expected life of the device, even if the company has ceased to manufacture, import, or distribute that device.
Presumably, FDA inspectors could find that an event should have been reported. Without extenuating circumstances, however, it is unlikely that any FDA enforcement action would result, as long as the decision not to report was rational and well documented. FDA is barred from seeking civil penalties for minor violations of the corrections and removals regulation if the company is in substantial compliance.6
The Report Contents. Under 806.10, companies must include the following in each correction and removal report.
- The seven-digit registration number of the entity responsible for submission of the report.
- The name, address, and telephone number of the company and the name, title, address, and telephone number of the company's representative responsible for conducting the device correction or removal.
- The brand name and the common name, classification name, or usual name of the device and the intended use of the device.
- Marketing status of the device; that is, any applicable premarket notification number, premarket approval number, or indication that the device is a preamendments device, and the device listing number. A company with no FDA establishment registration number must indicate in the report whether it has ever registered with FDA.
- The model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.
- The manufacturer's name, address, telephone number, and contact person if different from that of the person submitting the report.
- A description of the events giving rise to the information reported and of the corrective or removal actions that have been and are expected to be taken.
- Any illness or injuries that have occurred with use of the device. If applicable, the medical device report numbers must also be included.
- The total number of devices manufactured or distributed subject to the correction or removal, and the number in the same batch, lot, or equivalent unit of production subject to the correction or removal.
- The date of manufacture or distribution and the device's expiration date or expected life.
- The names, addresses, and telephone numbers of all domestic and foreign consignees of the device and the dates and numbers of devices distributed to each consignee.
- A copy of all communications regarding the correction or removal and the names and addresses of all recipients of the communications not previously provided to FDA.
- If any required information is not immediately available, a statement about why it is not available and when it will be submitted.
Clearly, the amount of information that needs to be reported is substantial. To efficiently implement these requirements, companies should immediately begin drafting SOPs that will clarify exactly what information is needed and who is responsible for gathering it.
Although FDA decided not to draft a corrections and removals reporting form, companies would be wise to include in their SOPs a form for initial reporting; a form for amending already reported corrections and removals; and a form recording corrections and removals not reported, with the appropriate lines for justifying why the report was not filed. Employees must then be trained on the parameters of the new regulation and the company's implementation procedures. Examples of such forms are included in Figures 1-3.
If the company decides that the correction or removal should apply to additional batches of the same device, an amendment to the original report must be filed within 10 working days. That report must include the number of the original report; the name, address, and telephone number of the manufacturer or distributor; the name, title, address, and telephone number of the representative selected to carry out the correction or removal; and any information otherwise required that is different from the information provided in the original report.
Figure 1. Sample correction and removal report.
Access to and Availability of the Reports. All information relating to corrections and removals, reportable or nonreportable, must be provided to FDA upon request. These reports are subject to disclosure under the Freedom of Information Act (FOIA). However, FDA will delete from the report any information that constitutes a trade secret or confidential commercial or financial information as defined under the agency's FOIA regulations. Any information that would constitute a clearly unwarranted invasion of personal privacy, such as medical information or serial numbers of implanted devices, will be kept confidential.7
Figure 2. Sample of an amendment to a correction and removal report.
Because these reports are generally available to the public, FDA recognizes that the information could be used in product liability suits. Consequently, the regulation provides that a submitted report "does not necessarily reflect a conclusion by the manufacturer, distributor, importer, or FDA that the report or information constitutes an admission that the device caused or contributed to a death or serious injury." The regulation further provides that a company may deny that the report constitutes an admission that the device caused or contributed to a death or serious injury. This provision is very similar to that in the MDR regulation to the effect that any MDR report to FDA does not necessarily constitute an admission that the device or the reporting entity or its employees caused or contributed to the reportable event (21 CFR 803.16). A company may deny that the report or information submitted under MDR constitutes an admission that the device, the party submitting the report, or employees thereof caused or contributed to a reportable event.
Figure 3. Sample of documentation for an unreported correction and removal.
Notwithstanding these provisions and a long history of using this disclaimer, plaintiffs' attorneys have sought to use MDR reports as evidence against manufacturers. It is safe to say that they will also seek to use correction and removals reports. Consequently, use of the disclaimer is recommended, although its effect in litigation will vary depending on the court's view of its relevance and the report's admissibility.
FDA believes that the new regulation will not be a significant additional burden to the industry. Approximately 800880 reports are expected to be submitted annually. This can be compared to the 76,380 reports that were submitted to FDA by manufacturers under the MDR regulation in fiscal year 1996.8
Although the number of reports expected under this regulation is limited, the regulation's implications to industry are important. First, an entirely new regulatory scheme has been imposed on the medical industry. No longer is reporting recalls or corrections voluntary. Second, new SOPs must be drafted, employees trained, and requirements observed. If a company fails to comply with the regulation, it is subject to the full panoply of penalties available under the FD&C Act.
FDA's redefinition of the risk-to-health standard has significantly reduced the potential burden caused by the new regulation. By tying the definition of risk to health to the already existing Class I/Class II definitions of recalls under 21 CFR Part 7, FDA has made implementing it much easier. If manufacturers understand the new requirements and train their personnel appropriately, the requirements should not be unduly burdensome, nor should there be a flurry of FDA enforcement actions. Companies should continue to work with the recall coordinators who will be primarily responsible for processing the reports. Any issue regarding reportability should be able to be worked out at the district level as long as the correction and removal is well documented.
1. Federal Register, 62 FR:27183.
2. Section 519(f), 21 U.S.C. 360i(f).
3. S. Rept. 513, 101st Cong., 2d Sess. 23 (1990).
4. Federal Register, 59 FR:13828.
5. Federal Register, 61 FR:2718327184.
6. 21 U.S.C. 333(g)(1)(B)(ii). See also 60 FR:38612 (procedures for hearings concerning the imposition of civil money penalties).
7. Federal Register, 62 FR:27183, 27193, to be codified at Code of Federal Regulations, 21 CFR 806.40(b)(2); see FOIA provisions on personal privacy, 5 U.S.C. 552(b)(6) implemented at Code of Federal Regulations, 21 CFR 20.63.
8. Annual Report, Fiscal Year 1996; Rockville, MD, FDA Office of Surveillance and Biometrics, p 23, 1997.
Jonathan S. Kahan is a partner in the law firm of Hogan & Hartson (Washington, DC) and a contributing editor and member of MD&DI's editorial advisory board.
Illustration by Ken Corrál