On February 22, 2013, the Food and Drug Administration (FDA) issued a draft guidance entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” (Docket No. FDA-2013-D-0114) (Draft Guidance). The purpose of the Draft Guidance, according to FDA, is to “clarify when a change to a device constitutes a medical device recall, to distinguish those instances from product enhancements that do not meet the definition of a medical device recall, and to identify the associated regulatory reporting requirements for each.” (Draft Guidance, lines 90-93)
The Draft Guidance applies only to voluntary recalls, whether they are commenced by the manufacturer on its own initiative or as the result of a formal request by FDA, as opposed to mandatory recalls. Mandatory recalls are governed by the Food, Drug and Cosmetic Act (the “FDCA”), 21 U.S.C. §360h. Voluntary recalls are governed by related regulations found at 21 CFR, part 7.
The distinction between whether an action constitutes a “recall” or a “product enhancement” is significant, because product recalls necessitate submission of a correction and removal report (also known as an “806 report”) to FDA (if the violation at issue may present a risk to health), often generate negative publicity, could damage the company’s reputation with customers, could reduce revenue of the product line or lines associated with the recall, and could have implications in subsequent lawsuits. What medical device companies previously viewed as improvements could now be considered recalls in some circumstances. Changes to products that constitute recalls can range from labeling changes to updates to instructions for implantation to component substitutions.
The regulations define a “recall” as “a firm’s removal or correction of a marketed product that the Food and Drug Administration 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.” 21 CFR § 7.3(g). A “market withdrawal,” in turn, is defined as “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 Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.” 21 CFR § 7.3(j). A “stock recovery” is “a firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm.” 21 CFR § 7.3(k).
The regulations do not define “product enhancement.” The Draft Guidance provides the following definition: “For purposes of this guidance document, product enhancement means a change or improvement to a non-violative device as part of continuous device improvement activities.” (Draft Guidance, lines 138-140) According to FDA, product enhancements include “changes designed to better meet the needs of the user, changes to make the product easier to manufacture, and changes to the appearance of the device that do not affect its use. A product enhancement is both (1) a change to improve the performance or quality of a device, and (2) not a change to remedy a violation of the [FDCA] caused by the device.” (Draft Guidance, lines 140-6)
Distinguishing between a product enhancement and a recall can be difficult. Essentially, FDA states that an action does not constitute a recall unless it is a change to a marketed medical device that addresses a violation of the FDCA. The changes could be to “1) the device design; 2) the manufacturing process; 3) the device labeling . . . . (including updating the labeling of a distributed product); and 4) marketing practices (e.g., a removal of the device from the market).” (Draft Guidance, lines 185-189).
FDA provided an example of a product enhancement and a recall relating to an approved implantable device that contained a battery with an estimated battery life of five years under normal conditions of use. A change to a new battery that extended the battery life to five and one-half years under normal conditions would constitute a product enhancement, not a recall. Similarly, including a new battery from a new supplier with a six-year battery life because the prior battery is obsolete would be a product enhancement rather than a recall. In contrast, FDA provided an example when a change would not be a product enhancement but rather a recall. Under the Draft Guidance, when a device manufacturer with two battery suppliers with an aggregate life of five years determines that the battery from one supplier is found to have a lifespan of four years rather than the specified five years due to manufacturing issue. Those devices that contained the battery that prematurely depleted would be subject to a recall even though the device as a whole had an average battery life of five years. (Draft Guidance, line 238)
Whether the change is made to correct a violation of the FDCA is not always clear. The Draft Guidance provides that, generally, devices that fail to meet specifications or fail to perform are considered “adulterated” and therefore violative of the FDCA. Changes to correct those failures would constitute recalls, according to the Draft Guidance. (Draft Guidance, lines 219-223). Similarly, the Draft Guidance provides that devices that are mislabeled or provide inadequate directions are considered misbranded under and therefore violative of the FDCA. As such, according to the Draft Guidance, corrections to false or misleading labels, which include pamphlets, instruction books, direction sheets, and websites, would constitute recalls. (Draft Guidance, lines 244-260.).
Of significant note is the statement in the Draft Guidance that even a product enhancement that does not constitute a recall may be reportable. (Draft Guidance, lines 260-263, 415-429). FDA provides the following examples of changes that do not qualify as recalls but nevertheless must be reported through an 806 report because they were “initiate[d] to reduce a risk to health posed” by the device: addition of new warnings to a label in order to reduce a health risk, a manufacturing change to reduce likelihood of contamination of a sterile device, and a “design change to improve a product’s safety profile.” (Draft Guidance, lines 415-429)
In short, the Draft Guidance provides that if “the result of [the manufacturer’s] assessment indicates that the change is made to a violative marketed device to bring it into compliance with the laws administered by FDA, then the change would most likely constitute a medical device recall.” (Draft Guidance, lines 267-269). Many updates that may not appear to be recalls could be interpreted as such, which would subject companies to more stringent requirements. Medical device manufacturers’ marketing, research and development, regulatory, quality assurance, and legal departments, among others, must be mindful of whether changes to their products or labeling could constitute recalls so they can ensure that they follow all of the procedures for recalls.
The FDA invited comments on the Draft Guidance. To date, seven public comments have been made available. Three of those comments were submitted by the industry, while the other four were submitted by individuals. While the substance of the comments varies, the comments generally raised the following concerns about the Draft Guidance’s:
- creation of additional and potentially burdensome reporting requirements for product enhancements;
- definition of “product enhancement,” including that it is potentially subjective, which could lead to inconsistent interpretation by industry and FDA;
- discrepancies between definitions included in the guidance and those provided in the established regulations;
- inclusion of the term “product enhancement” in the definitions of “correction” and “removal,” which potentially and incorrectly could equate a product enhancement with a recall;
- absence of definitions of “violation” and “violative device,” which definitions would assist manufacturers in determining whether an action is a recall or an enhancement;
- imposition of definitions and reporting requirements through a draft guidance rather than the rulemaking process;
- lack of clarity in the example and flow chart included in the guidance and the scope of devices covered by the guidance document; and
- eliminating the manufacturer’s discretion in determining whether an action is a recall or an enhancement.