The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of clarification, major revisions or outright 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 by the agency as a recall, even if the action is conducted voluntarily, as they often are.
In those cases, manufacturers are required by 21 CFR 806 to submit to FDA various pieces of 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).
Withdrawal: Not Quite a Recall, But…
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New Draft Guidance
On 21 February 2013, FDA released a new draft guidance document aimed in part at establishing the requirements for distinguishing between defect- or failure-based recalls and products recalled for improvements.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.
Almost as soon as FDA released the guidance, some in industry flagged it has having major deficiencies. Most prominent among those voices thus far has been Jeffery Shapiro, a medical device lawyer who writes for the popular industry legal blog FDA Law Blog. Shapiro took issue with the guidance document's purpose, charging that it served more to "regurgitate" existing regulatory provisions rather than define and explain the terminology used by those regulations.
Shapiro said the guidance should have explained the agency's definitions of the following:
- 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?"
Worse, Shapiro said the guidance may well be improper because it creates what he called "new reporting requirements" under 21 CFR 806 that are unauthorized by either law or regulation.
"The minimal reasoning supplied to support this new requirement is difficult to understand if not completely incoherent," he added.
Other members of industry have expressed similar confusion.
Boston Scientific had significant recommendations for the guidance, which it submitted in comments to the FDA Docket. In at least one area, the guidance has failed, the company said.
"We have spent much time with our colleagues within the company and through trade associations discussing this draft guidance document," it wrote. "We are struck by the fact that it seems to be generating a significant amount of debate and divergent conclusions, and therefore worry that the draft guidance document has not achieved its purpose in clarifying the difference between product enhancements and recalls."
In other words, what good is a guidance document that doesn't provide clear guidance? While stopping short of calling for the wholesale removal of the guidance document, as Shapiro did, Boston Scientific did call for significant revisions to various sections of the guidance.
Elsewhere, the company also agreed with Shapiro's contention that the definitions of "correction" and "removal" in the guidance were not in harmony with 21 CFR 806, and are thereby an improper use of a guidance document. Such definitional changes require the use of the rulemaking process, it said. That said, the company added that the definitions used in the guidance were confusing and inconsistent with one another. "We believe that FDA's introduction of 'product enhancement' in the definitions of 'correction' and 'removal' introduces conflicting definitions within the guidance document, and should be avoided," it said.
The problem, it continued, was that by closely associating corrections, recalls and "product enhancements," FDA was "in effect" equating all to one another despite the latter explicitly not being a recall, and thus giving the latter a "negative connotation" as well.
"Therefore, for the reason outlined above, we respectfully request that the definitions of 'correction' and 'removal' not be modified and remain as they appear today in 21 CFR § 806," the company asked.
Other Identified Problems
Other problems cited by Boston Scientific include:
- The guidance is "too broad and should be narrowed."
- The guidance encompasses too many minor changes that are made not for reasons of health and not to "remedy a violation," like replacing an obsolete part or meeting new standards.
- The guidance does not define "violation" or "violative device."
- The requirement to report certain product enhancements is "unnecessary, burdensome and fundamentally at odds with legislative intent and existing regulatory language."
- The guidance is redundant with other existing regulations, including 21 CFR 807 and 814.
- The guidance's plan to determine appropriate premarket and postmarket actions "exceeds the authorities provided under 21 CFR 806."
"Because of the significance of the changes being proposed, including changes that appear to warrant a notice of rulemaking, we hope that FDA will consider further consultation with the industry prior to issuing a document in final form," it said.
Manufacturer Merck, meanwhile, was more conservative in its comments, saying only that it needed two points in particular to be clarified. The first of those clarifications regards what the guidance means when it says "all other products, including electronic products that do not meet the definition of a device, are outside of this guidance." Merck said this language was ambiguous regarding whether the agency meant to include combination products or not.
In addition, Merck said it needed further FDA clarification regarding whether transportation, distribution, or supply chain changes would constitute a product enhancement or a recall.
FDA Docket on Recall Guidance