Medical Device Link.

Originally Published MDDI December 2004

Regulatory Outlook

Larry R. Pilot

Among the products subject to litigation for alleged damages are those regulated by FDA. From one perspective, FDA regulation can provide a defense against the possibility of recovery for damages incurred. However, FDA involvement can also become a source of information, facts, and liability theories that can increase a product’s exposure to liability.

Before the Medical Device Amendments of 1976, FDA had no authority to recognize or mandate a recall or remedial action for any product subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, FDA did have an enforcement policy to define and classify the nature of a recall.

This policy, which appears in 21 CFR Part 7, has been in effect since the 1970s.¹ Its aim was to develop criteria for what constitutes a recall. The policy also defines the level of seriousness of a recall in relation to health risk. Because the point of a recall is for the manufacturer to voluntarily correct alleged FD&C Act violations, FDA created a way to order a recall if a manufacturer will not take remedial action.

Terms and Definitions

Although the dictionary definition for the term recall has various applications, the term as defined by FDA has regulatory implications that are not considered by the dictionary definition. FDA defines recall, correction, and market withdrawal as follows:

• Recall means 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, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.²
• Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.³
• Market withdrawal means a firm’s removal or correction of a distributed product that involves a minor violation that would not be subject to legal action by FDA or that involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.⁴

The essence of FDA’s recall definition is the activity that FDA “… considers to be in violation of the laws that it administers and against which the agency would initiate legal action…”

Whether correction of the alleged violation is addressed by physical removal or other means, FDA’s identification of the activity as a recall signifies the agency’s belief that a violation of the FD&C Act exists. A device may be withdrawn from the market, or it may qualify for remedial activity without violating the FD&C Act.

Consequently, individuals responsible for field activities must avoid admitting a violation. Interpretations of the requirements of the law and regulation may differ as to whether a violation exists. Regardless, FDA applies its definition of recall to determine the nature of the action. The ultimate resolution of any disagreement about whether there is a violation is a function of the judicial process.

In some cases, FDA believes that its evidence does not provide support for a voluntary remedial action. The agency may then determine that a violation represents “a reasonable probability” of “serious adverse consequences or death.” In these cases, FDA may formally request initiation of a recall. If the recipient of the request is unwilling to act, FDA (through the Department of Justice) may seize the devices or enjoin their distribution. Likewise, those responsible for causing the violation can be prosecuted. In either event, the burden is on FDA to prove its position in federal court.

Recall Order

Before the 1990 amendments, infant formula was the only product under the authority of the FD&C Act to be subject to FDA recall. The 1990 amendments authorized FDA to order a recall under certain conditions. Where FDA finds “…that there is a reasonable probability that a device intended for human use would cause serious adverse health consequences or death…” FDA must issue an order. This order, which is expected to state the grounds supporting the order, also directs that distribution cease, and it requires the manufacturer to notify affected parties.

FDA must also offer a formal hearing to those parties who are subject to the order. The medical device recall authority regulation addresses this authority.⁵

Because the explicit language in the FD&C Act limits application of the potential for an order, this regulation provides a different definition for the term recall, and it provides an explicit definition of removal. These definitions are as follows:

• Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious adverse health consequences or death.
• 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.

To order a recall, FDA must first provide the appropriate person with the opportunity to consult with FDA. After consultation, FDA has the burden to find “…that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death…” to support its order. A recall order specifies the actions that are to be taken by the named person. The order also includes the following immediate requirements: cease distribution, notify health professionals and user facilities, and instruct the user and user facilities to cease use of the device. In addition, the following information is included in the order:

• The requirements of the order that relates to the cessation of distribution and notification of health professionals and device user facilities.
• Pertinent descriptive information that would enable accurate and immediate identification of the device subject to the order, including the brand name of the device; the common name, classification name, or usual name of the device; the model, catalog, or product code numbers of the device; and the manufacturing lot numbers or serial numbers of the device or other identification numbers.
• A statement summarizing the grounds for FDA’s finding that there is a reasonable probability that the device would cause serious, adverse health consequences or death.

Other information can also be included in the order, but the manufacturer may request a hearing to appeal the order. Alternatively, manufacturers may submit a written request to FDA that the order be modified, vacated, or amended. If an appeal is pursued, FDA issues its response within 15 working days of completion of its review (i.e., hearing or receipt of written request).

FDA’s modified or amended order is a final agency action for which the appropriate person may seek judicial relief. Since the 1997 effective date, at least one order has been issued. Voluntary compliance with FDA enforcement policy on recalls appears to be an adequate method for addressing remedial actions for alleged FD&C Act violations.

Corrections and Removals

The 1990 amendments authorized FDA to require a manufacturer to report promptly to FDA any device correction or removal taken to reduce a health risk posed by the device. Manufacturers must also report the action if it is taken to remedy an FD&C Act violation that may present a health risk.

The reports of corrections and removals regulation became effective March 27, 2000.⁶ It differs from the long-standing FDA policy relating to voluntary recalls and market withdrawals and from FDA’s policy relating to the mandatory recall order process. Unlike these regulations, the corrections and removals regulation imposes a direct burden on device manufacturers. Simply put, manufacturers must make a judgment call relating to what the regulation expresses as “risk to health.” If the anticipated removal or correction is taken to reduce risk, a report must be submitted to FDA within 10 days of initiating the removal or correction.

The legal requirement to notify FDA of corrections and removals imposes an unusual and challenging burden for device manufacturers. Failure to notify FDA of this type of recall is a violation of the FD&C Act. There has been no litigation to enforce a penalty against those who have failed to comply with the corrections and removals regulation. However, the potential is realistic, depending on the regulatory environment. Individuals responsible for reviewing complaints, filing medical device reports, and participating in the review of remedial actions relating to a device must also consider notifying FDA as part of their responsibility.

The 1990 congressional mandate is not explained well, but it is clear that a manufacturer’s decision to report must be based on “risk to health.” FDA defines the phrase as follows:

• A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or
• 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.

When a manufacturer contemplates remedial action for a device in commercial distribution, this risk to health definition must be considered when deciding whether to report the action to FDA. This decision-making process should also involve reviewing definitions from other FDA regulations (e.g., medical device reporting (MDR), enforcement policy, medical device recall authority, etc.). Manufacturers should develop a procedure for remedial actions. Because of the implications of such actions, it is essential to include the opinion of a medical advisor as to whether to file a corrections and removals report.

Another important factor to review in a health risk evaluation is the regulation’s reference to violation. Something could go wrong with a device that is properly designed, manufactured, and used. However, the complicated structure of statute and regulation makes the determination of a violation difficult. FDA and the manufacturer may disagree as to whether a violation has occurred. Ultimately, it is up to FDA to prove that a violation exists. Consequently, both FDA and the manufacturer must be cognizant of due process and the quality of the evidence.

Manufacturers must apply and document their remedial-action approach. It is important to keep in mind that FDA may challenge the method chosen. One approach is to evaluate the performance of devices as part of a complaint-handling process and as part of the firm’s application of its MDR procedure. If application of a documented procedure suggests the need for correction or removal as a remedial action, then an assessment of health risk is indicated. This is a difficult task. It is also difficult to determine whether the cause of an identified health risk is related to an FD&C Act violation.

Likewise, FDA must understand the difficulty associated with the decision-making process. The corrections and removals regulation and its preamble provide no explicit guidance. Consequently, when evaluating a manufacturer’s judgment, FDA must apply discretion and consider the type and variety of devices and the conditions under which the device is used. FDA should cooperate with manufacturers and agree on an approach appropriate for the nature of the risk.

When judgment is required, no provision in a regulation can function as a surrogate. There is no motivation for manufacturers to market unsafe or ineffective medical devices. The potential for product liability lawsuits because of injury to users is a potent ancillary to the regulatory function of FDA.

The concept of risk assessment exists as part of the quality system regulation, but the device industry should also participate in the process of developing and implementing a fair and balanced approach to risk assessment in relation to product benefit.

In the meantime, device manufacturers should also implement procedures to identify health risk. Manufacturers should recognize, however, that FDA might challenge the outcome of the application of a company’s risk-assessment procedure. If the challenge occurs as part of a routine FDA inspection or as an initiative by CDRH, the best possible defense to a challenge will be the company’s documentation indicating compliance with a comprehensive procedure.

Managing Field Corrective Actions

Regardless of the reason for remedial field corrections, a conscientious manufacturer should aim to correct the problem to maintain customer loyalty and satisfaction. Once FDA determines that a manufacturer has voluntarily corrected a violation, the agency has explicit procedures it expects the manufacturer to follow. These procedures are described in the recall regulation in 21 CFR Part 7, Subpart C, as well as in FDA guidance documents.

FDA reviews information collected from the manufacturer. A health-hazard evaluation is conducted to determine a recall classification. Possible recall classifications include:

• Class I: There is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• Class II: Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
• Class III: Use of, or exposure to, a violative product is not likely to cause adverse health consequences.

The classification determines FDA’s expectations of the manufacturer’s recall strategy. The strategy varies depending on the health risk and device type. The recall of a life-supporting or life-sustaining device may require direct contact with the user and possible assistance, including publicity, from FDA.

FDA’s recalls regulations and a guidance for industry released in November 2003 provide useful information and advice for developing a procedure. FDA also looks at the effectiveness of a recall. The regulations and the guidance document address how FDA ensures effective completion of a recall.

Although there is a benefit to the prompt and effective completion of a remedial action, completion also indicates the eventual disclosure of FDA documents under the Freedom of Information Act. The quality of the manufacturer’s performance will determine whether the content of such documents encourages or discourages product liability complaints.

Conclusion

In a world of perfect device performance, there would never be a need for a remedial action. This is unrealistic. Therefore, in the quest for device perfection, it is important to recognize that even with the best design and foresight as to a product’s use, something could go wrong. If something does go wrong, the procedure that one never expected to use should represent the preparation that enables a manufacturer to maintain user confidence and loyalty and avoid needless litigation.

References

1. Code of Federal Regulations, 21 CFR Part 7.
2. 21 CFR Part 7, Section 3 (g).
3. 21 CFR Part 7, Section 3 (h).
4. 21 CFR Part 7, Section 3 (j).
5. 21 CFR Part 810.
6. 21 CFR Part 806.

Copyright ©2004 Medical Device & Diagnostic Industry