When is a recall not really a recall? Between the US Food and Drug Administration (FDA) and industry, this has long been a point of contention.
Recall regulations stipulate that any action taken by a manufacturer to correct a defect or performance failure that could pose a risk to public health may be defined as the agency as a recall, even if the action is conducted voluntarily, as it often is.
In those cases, manufacturers are required by 21 CFR 806 to submit to FDA various information, including the product name, model, approval or clearance number, lot/unit number, and a reason for the recall. The latter should, according to FDA's Guidance for Industry: Product Recalls, Including Removals and Corrections, include a detailed explanation of how the product is either defective or violative, how it affects the safety of the product, the nature of the defect and any information on how users should protect themselves in the meantime.
But those cases are only for when a product is defective or violates a particular set of standards or regulations, such as current good manufacturing practices (CGMPs).
Some companies exhibit recall-like behavior, but for very different reasons, such as ending a product or replacing it with a new version that improves upon the existing design. These are not recalls, and do not need to be publicly announced.
"When new iterations of a device involve improvements to device design, it does not necessarily mean that the existing device needs to be recalled," FDA explained. "Such changes may be appropriately characterized instead as product enhancements."
The trouble, then, is when the latter masks the former, such as a company recalling a product from shelves under the guise of it being for product improvements, when in reality it was for a deficiency.
It can be difficult for FDA to press manufacturers on this point, as they lack a regulatory definition of what a "product enhancement" is. In its guidance, it says that such an action may be defined as "a change or improvement to a non-violative device as part of continuous device improvement activities."
New Draft Guidance
On 21 February 2013, FDA released a new draft guidance document aimed in part at establishing the requirements for distinguishing between defect- or failure-based recalls and products recalled for improvements.
The guidance is laid out in a question-and-answer format that it believes will be "helpful in identifying medical device recalls and applying the reporting requirements."
For example, FDA explains that, "Only changes to devices to remedy a violation of the laws administered by FDA and against which the agency would initiate legal action fall within the definition of a medical device recall."
"For example, if a device is being corrected to address a Quality System violation (see 21 CFR part 820), the correction would generally be considered a recall." Meanwhile, if the device has no violations, it would be considered a product enhancement or stock recall.
But what is a violation, anyway? The guidance explains that FDA considers any device that fails to meet specifications, fails to perform as intended, is below the quality the device represents itself as having, or is adulterated or misbranded would constitute a violation, and would thus constitute a recall if removed from the market.
"A firm's risk management activities will help provide a reference for known failure modes and expected or estimated failure rates," FDA continued. "An increase in overall failure rate, increase in a single failure mode rate, or the identification of a new failure mode would indicate a failure to perform as intended. A change to the marketed device to address a failure to perform to specifications, or a failure to perform as intended, would constitute a medical device recall."
Recall reports are required to be submitted to FDA as an 806 Report within 10 days of the recall being initiated. In addition, if a firm conducts a product enhancement that is intended to reduce a risk to health, it is similarly required to report to FDA all relevant information under an 806 Report.