Compliance Notes

by Anna Longwell, Esq.

Medical Device Compliance Note: Recalls, Removals and Corrections, and Medical Device Reporting

Product problems will occur, in spite of the best quality systems and the most well intentioned manufacturers. When they do, Medical Device manufacturers are constrained by more regulation than are makers of other medical products, such as drugs.

The oldest regulations (c 1973) address only one type of medical device, those which are also radiation-emitting products falling under the repair, refund, replace regulation at 21 CFR 1004. These regulations cover defects that could cause unnecessary radiation exposure, as well as defects that make the product fail an FDA electronic product standard. . The maker or seller of such products has very little leeway in determining how to deal with these defects. I will not go into these regulations here, as they are of less-than-general interest. However, the Radiation Health website at , has a lot of excellent information. I will simply say that some response (either repair, replace, or refund) is mandatory. And, unless waived by FDA, a notice under 21 CFR 1003 must be sent to FDA (Center) and to the purchaser, and to any intermediary, such as a distributor.
The term “recall” is defined at 21 CFR 7, a regulation that applies to foods, cosmetics, drugs and devices. Devices that are also electronic products are excluded. This section of the regulations describes a voluntary system (guidance) for managing recalls, classifying recalls by evaluating risk of product defects, and reporting to FDA. In my experience, about 50% of device firms followed this voluntary procedure after it was published in 1978. A “recall” is a removal or correction of a product that the FDA would consider violative, and against which FDA would initiate action. Correction is simply some activity that corrects the defect without taking the product back. For example, a letter to customers informing them of a software bug and telling them about a work-around is still a “recall”, if the bug rendered the product violative. A recall is a field corrective action to remedy a product problem that makes the product adulterated (not made under GMP, not meeting release specs, design control defective, etc.), or misbranded (labeling false or misleading, or required statement missing, etc.). Much controversy has arisen because FDA also included a definition of a “market withdrawal” in this regulation. A market withdrawal is a correction or removal conducted to remedy a product defect that either involves no violation, or involves such a minor violation that FDA would not consider legal action. NOTE: FDA’s notion of a “minor” violation is not intuitive. A good example of a “minor” violation would be printing the company logo upside down. Technically, the product is mislabeled, but FDA would not prosecute. Most of the time, if a product defect means the product does not work the way its labeling says it should work, FDA will consider the product violative, and the corrective action will be a recall. FDA classifies recalls reported to them into three categories, depending on the level of health risk presented by the problem being corrected. Class I is the highest risk, Class III the lowest.

In the 90′s, in response to the Safe Medical Devices Act, FDA developed some additional regulations, only for the medical device industry. The first of these was the Medical Device Reporting (MDR) regulation at 21 CFR 803 (1995). This regulation is designed to let FDA know about deaths and serious injuries caused by, or possibly caused by, medical devices. However, FDA did not limit itself to actual cases of death or serious injury. This regulation also requires manufacturers to evaluate reports of device malfunction not involving death or serious injury, and determine whether, were the malfunction to recur, a death or serious injury would be likely. The regulation says nothing about whether the recurrence would be likely. That is, if the possibility of a recurrence of a malfunction were very remote, but if it did occur, a death or serious injury would be likely; a medical device report is required. These reports are made to FDA (Center). The MEDWATCH form is used to report MDRs, and the content is described in the regulation. The majority of MDR reports are 30-day reports, meaning that they must be at FDA within 30 days of the manufacturer becoming aware of the incident. There are provisions for 5-day reports if the manufacturer believes there is serious risk to public health requiring remedial action. If an MDR report is required for an electronic product incident or malfunction that would also qualify as an electronic product defect, only an MDR need be filed.

The next two regulations addressing device product problems were published in 1996 and 1997. The ’96 regulation is at 21 CFR 810, and gives FDA authority to order a device recall. Note: the definition of “recall” in this regulation is slightly different from the one in part 7, in that it is not as all-inclusive. It is analogous to the Class I recall of part 7.

FDA does not have recall authority for drugs, cosmetics or foods. FDA can suggest to these other regulated industries that they perform a recall, and most prudent companies will comply. To force a recall, FDA has to go to court and obtain an injunction requiring recall. For devices, FDA can order a recall when a product presents a serous risk to health. FDA will first require that the product cease distribution and that all users be notified to cease use of the device. Then, after a hearing, FDA can require that the product be recalled, and can specify whether the recall should extend to the wholesale, retail or user level. The kind of product problem that would trigger this response is roughly analogous to the class I recall described in part 7. In general, most firms will conduct voluntary recalls for such problems. This regulation will only be invoked if the manufacturer and the FDA disagree markedly about the seriousness of the product problem.

The final regulation 21 CFR 806, published in 1997, describes a requirement for reports to FDA for device field corrective actions. Unlike the reports we have described prior, these reports are sent to the District Office in the manufacturer’s District. While part 7 describes similar reports for recalls, part 7 is guidance, not a requirement. However, as of 1997, device manufacturers have to keep specific records, which are open to FDA inspection, for all field corrections. They must also determine whether the field corrective action (removal or correction) is reportable. Corrections or removals are reportable within 10 days of starting the correction/removal, under two conditions.

First, if the product problem makes the product violative, and the product problem presents a risk to health, the correction/removal is reportable. (This condition is analogous to Class I and Class II recalls described in part 7). Corrections of violations that do not present a risk to health are not reportable.

Second, whether or not the product is violative, if the corrective action is undertaken to reduce a risk to health, the correction/removal is reportable.

Risk to health is defined in two ways. A risk to health exists when use of, or exposure to the device has a reasonable probability of causing serious adverse health consequences or death (this is essentially the Class I recall risk level). A risk to health also exists when use of or exposure to the device causes a remote possibility of serious adverse health consequences or death, or a reasonable possibility of temporary or medically reversible adverse health consequences (this is essentially the Class II recall risk level). Therefore, a product posing remote possibility of temporary or medically reversible health consequences is not a risk to health, per this regulation. Corrections undertaken to reduce the remote possibility of temporary or medically reversible health consequences are therefore not reportable. (These are the Class III risk level) However, records must be kept of all corrections and removals, and the reasons for the decision not to report must be included. ALL communication regarding the correction or removal must be in the file. If there is documentation of controversy over whether or not a particular corrective action is reportable, the controversy must be resolved before the file is considered complete. As with the electronic product reporting requirement, if the information on the device correction has been sent to FDA under the MDR reporting regulation, a report of removals and corrections need not be filed.

To recapitulate, device product problems and the actions taken to correct the problems must be reported to FDA under a number of different regulations, each with slightly different requirements. MDR reporting will eliminate the requirement for 806 or 1003 reporting for the same product problem, as long as the information required by these regulations is included in the MDR report. The regulations at part 7 are now of little interest to device manufacturers, except to provide insight into how FDA will classify your corrective action, if it is reported to them.