Post-Sale Duties: FDA Law and Regulations

Introduction

As described in the previous article, manufacturers of medical devices sold in the United States have two bodies of laws to consider after sale: the common law of product liability and FDA laws and regulations. Compliance with one body of law does not guarantee compliance with the other body. In addition, since post-sale responsibilities are expansive in scope and time, it is sometimes difficult to know whether you have met your legal duties.

In the previous article, I described the common law duties based on negligence. Knowing the risk of injury from the product based on field experience, did the manufacturer do enough to minimize the risk? It is a jury question and can be very difficult to defend. The plaintiff will always be able to propose something additional that the manufacturer could have done to warn of the prouct's risk or to fix the hazard.

The FDA requirements are fairly extensive, but there is a great deal of flexibility in how to implement a recall and how effective it must be. The bottom line is that the manufacturer must strive to meet or exceed the FDA requirements for post-market surveillance and reporting as well as undertake appropriate recalls in order to argue that it complied with all FDA requirements, was not required to do more, and was not negligent.

This article will discuss some of the FDA requirements and guidances in the post-sale area including recalls and other corrective actions.

Regulatory Law

Postmarket Requirements Before Recalls

Medical device manufacturers, as well as other firms involved in the distribution of devices, must follow certain requirements and regulations once devices are on the market. These include maintaining product tracking systems and reporting device malfunctions, serious injuries or deaths. They also include postmarket surveillance studies required under section 522 of the act.

According to the FDA:

Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided FDA with two additional postmarketing activities, Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level.

(The MDR guidance can be accessed here.)

In addition, the Manufacturer and User Facility Device Experience Database (MAUDE) contain reports of adverse events involving medical devices reported by hospitals starting in 1991. Manufacturers have been required to submit reports since 1996.

Next, device manufacturers under FDA’s Quality System Regulation must establish a “Corrective and Preventive Action” (CAPA) program (21 CFR Sec. 820.100). While many of the elements of such a program are to be performed before distribution of the device, many of them will be performed after distribution as quality problems arise and need to be corrected. Therefore, a compliant CAPA program is an integral part of any postmarket program.

Last, on July 3, 2012, the FDA issued a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. The FDA describes a UDI as follows:

A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center.

The FDA worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule and is seeking comment on the proposal for 120 days. The rule can be found in the July 10, 2012 Federal Register.

Recalls

Device manufacturers are required to report to the FDA any corrections or product removals (21 CFR Sec. 806.10) within ten working days of initiating a device correction or removal. Where there is a recall, the manufacturer must inform the FDA “immediately” upon deciding to remove or correct a product (21 CFR 7.46(a)).

The basic requirements for recalls appear in the Code of Federal Regulations, Title 21, Part 7, Subpart C, Sections 7.40 through 7.59. While these are part of the federal regulations, this subpart is referred to as “Guidance on Policy, Procedures and Industry Responsibilities.”

Various statutory provisions and regulations authorize FDA to require recalls of certain products in specific situations. The Code of Federal Regulations (21 CFR Sec. 7.45) in general says:

(a) The Commissioner of Food and Drugs or designee may request a firm to initiate a recall when the following determinations have been made:

(1) That a product that has been distributed presents a risk of illness or injury or gross consumer deception.

(2) That the firm has not initiated a recall of the product.

(3) That an agency action is necessary to protect the public health and welfare.

Additionally, the CFR’s provide general guidance for the voluntary recall of products, including those recalls initiated by a firm on its own and at the FDA's request. In 21 CFR Sec. 7.46, it says:

(a) 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 Food and Drug Administration district office listed in 5.115 of this chapter.

When a company undertakes a recall, the FDA performs a Health Hazard Evaluation to assign the recall a classification based, in part, on probability and severity of harm. (21 CFR Sec. 7.41). Class I is for hazards that will cause serious adverse health consequences or death. A class II hazard is for the remote probability of temporary or medically reversible adverse health consequences. And class III is where a violative product is not likely to cause adverse health consequences.

Next, the federal regulations discuss a recall plan and strategy for the device manufacturer (21 CFR Sec. 7.40 and 7.42). The FDA will work with the manufacturer to develop a plan and strategy. The strategy includes the depth of the recall (or how far down the chain of distribution the recall will go), the type of warning message that is appropriate, and what effectiveness checks should be undertaken after the recall is initiated. The desired effectiveness of the recall (i.e. return rate) goes up the higher the level of hazard.

This subpart also talks about public notification by the manufacturer (Sec. 7.49) and by the FDA (Sec. 7.50). And, last, it provides for the filing of periodic status reports and terminating the recall.

The FDA issued another guidance in 2003 called “GUIDANCE FOR INDUSTRY: Product Recalls, Including Removals and Corrections.” It is described as follows:

This guidance is intended to assist those members of industry regulated by the Food and Drug Administration (FDA) in handling all aspects of a product recall, including all corrections and removals. The guidance includes a checklist of documentation and information that FDA utilizes to evaluate, classify, monitor and audit product recalls.

Two more documents might be useful in trying to anticipate how the FDA will interpret and implement their recall procedures. Chapter 7 of the Regulatory Procedures manual provides policy, definitions, responsibilities, and procedures for agency units to initiate, review, classify, publish, audit and terminate recall actions and implements 21 CFR Part 7 Subpart C described above. The second document is Chapter 8 of the FDA’s Investigations Operations Manual on Recall Activities.

Conclusion

All of these FDA documents do a good job of providing a framework for reporting to the FDA and implementing a recall. However, to the extent that your recall is not 100% successful, there still could be a question as to whether you could have done better.

While compliance with FDA recall requirements is not an absolute defense in a products liability case, it can go a long way in showing that you complied with the regulatory requirements and tried to do your best by relying on the FDA’s recall experts and guidance's.

Kenneth Ross

Kenneth Ross is Of Counsel to the Minneapolis office of Bowman and Brooke LLP where he practices in the areas of product safety and liability prevention and advises manufacturers, product sellers and insurers on ways to identify, evaluate and minimize the risk of products liability and contractual liability. These guides do not constitute legal advice and are very general. You should consult competent legal counsel or Medmarc Loss Control before acting on any of the information in these guides.