The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has finally put the finishing touches on a controversial guidance regarding how to distinguish the recall of a device from a market withdrawal.
On 21 February 2013, FDA released a draft guidance document aimed in part at establishing the requirements for distinguishing between defect- or failure-based recalls and products recalled for improvements or "enhancements."
The guidance, "Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements," was necessary, FDA said, because there is widespread confusion over what constitutes a recall, and what constitutes a product removal.
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 a company recalls a product voluntarily.
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 sales of a product or replacing it with a new version that improves upon the existing design. According to FDA, these are not recalls, and thus 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design, it does not necessarily mean that the existing device needs to be recalled," FDA explained in its February 2013 draft guidance. "Such changes may be appropriately characterized instead as product enhancements."
However, there are plenty of cases when there is overlap between the two definitions, such as when a company removes a product from the shelves to correct a cosmetic issue while there is also a safety alert covering the device.
Making things still more difficult: FDA lacks a regulatory definition for what a product "enhancement" is. "Neither the FD&C Act nor FDA’s regulations define device enhancement," FDA noted in its guidance.
Instead, device enhancements are mostly defined by what they are not. And since they're not a recall, FDA said it took the term to mean "a change or improvement to a non-violative device as part of continuous device improvement activities."
Guidance and Controversy
FDA's February 2013 draft guidance was greeted with a significant amount of criticism from members of the medical device industry, both for what the guidance addressed and for what it did not. For example, critics said FDA had missed an opportunity to define many important terms, including:
- When is a recall "initiated?"
- What constitutes a "risk to health?"
- Does an improvement need to address a failure, or can it just be a baseline improvement in safety?
- What constitutes a "minor violation" under the regulations?
- What's the difference between a "stock recovery" and a "correction?"
Other critics said FDA's guidance was strange in that it created "new reporting requirements" under 21 CFR 806 that were unauthorized in either law or regulation. Boston Scientific, for example, noted that the definitions of "correction" and "removal" in the guidance were not in harmony with 21 CFR 806, and were therefore improper.
[For more, please see Regulatory Focus' July 2013 article on the guidance.]
New, Final Guidance
FDA apparently took some of that criticism to heart, releasing a final guidance document that makes many changes relative to the February 2013 draft.
In a Federal Register announcement on the release of the final guidance, FDA said that in response to the comment, it had "revised the guidance document to enhance clarity through the inclusion of multiple new examples." And those examples are considerably more concise, with the guidance coming in at just seven pages—six shorter than the draft guidance.
Some of the biggest changes have to do with contested definitions. Consider the following to explanations of the term "correction" from FDA's guidance documents:
- Draft: "Correction means repair, modification, adjustment, relabeling, destruction, or inspection
(including patient monitoring) of a product without its physical removal to some other location (21 CFR 7.3(h) and 21 CFR 806.2(d)). Depending on the circumstances involved, a correction can be a recall or product enhancement."
- Final: "Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal to some other location."
Now consider changes to the definition of "removal" in the documents:
- Draft: "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. (21 CFR 806.2(i)). Depending on the circumstances involved, a removal can be a recall or product enhancement."
- Final: "As used in the definition of “recall” at 21 CFR 7.3(g), removal means the physical removal of a device to some other location for repair, modification, adjustment, relabeling, destruction, or inspection."
Both definitions opt to strike the line regarding the ambiguity of the action in favor of a more concise definition.
More importantly, FDA's guidance no longer contains one highly contested line that "reports of correction and removals under 21 CFR Part 806 may be required for corrections and removals regardless of whether the implemented change meets the definition of a medical device recall." FDA now asks simply that companies maintain records of the correction or removal for a period of two years, but doesn't ask for them to be reported to FDA.
In addition, FDA has now included a definition for the term "routine servicing" in the guidance, which is taken to mean "any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing."
Also of note: The guidance now has a new name, Distinguishing Medical Device Recalls from Medical Device Enhancements.