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FDA’s multi-layered rules for product recalls – corrections or removals of marketed devices that don’t comply with FDA rules – represent a double-edged sword.
If you’re not careful, it’s easy to under-report recalls. On the other hand, a quick reading of the regulations can cause you to over-report, needlessly shaking patient confidence and shareholder value.
How can you make the right decisions and ensure compliance? Start by understanding the key rules in play, then use a four-step decision process (outlined in Exhibit 1) to more efficiently and thoroughly meet your FDA obligations for product corrections or removals.
Exhibit 1: 21 CFR Part 806 Process Flow (Click to view larger PDF)
Parts 7 and 806: The Key Regulations for Product Recalls
At the outset, you need to know the differences between 21 CFR Parts 7 and 806 – the two key rules governing product recalls for FDA-regulated companies. Part 7 is FDA’s general rule for voluntary recalls, impacting not just devices but also drug and food products. In contrast, Part 806 is FDA’s rule specifically for medical device recalls.
Furthermore, Part 7 is an FDA request, while Part 806 is an FDA requirement. Specifically, under Part 7.46, you are requested by FDA to report corrections or removals as soon as possible. Under 806.10, however, you are required to report a correction or removal within ten business days. Note the important difference in the reporting deadlines set by the two rules.
Part 7 provides a scheme for classifying recalls based on the potential magnitude of the risk if the products remain in use. Classifications range from Class I recalls with the highest risk potential to Class III recalls with the lowest risk potential. In contrast, Part 806 addresses corrections and removals “initiated to mitigate the potential for adverse health consequences (my emphasis added).” Similar to Part 7, Part 806 wants you to consider the potential risk magnitude, but its reporting requirement is based first and foremost upon the intent behind your actions, with the goal of mitigating health risks no matter how serious or extensive.
For the most comprehensive recall evaluation, I recommend that device manufacturers focus primarily on the requirements of Part 806 and view Part 7 as a supplemental, piggyback guidance. Too many device manufacturers do just the reverse. They turn first to Part 7, spend too much time anticipating the classification that FDA might apply to their recall (thus risking not meeting the ten-day reporting deadline) and only later consider the potential health consequences of their actions.
Here’s a sequential approach that – in most cases – will help ensure that you follow the reporting and documentation provisions of Part 806, while still meeting FDA’s more general expectations under Part 7.
Step 1: Decide if a Health Risk or Legal Violation Exists
First, determine if the situation presents a risk to health according to the definition in Part 806.2(j). You must decide if there’s a “reasonable probability that use of or exposure to” your product may cause serious adverse health consequences or death. FDA doesn’t define “reasonable probability,” so a prudent manufacturer should take an extremely conservative approach and consider all possible risks.
Also, as part of this initial step, you must consider whether the situation involves a violation of the Food, Drug and Cosmetic Act or any applicable FDA regulation. For example, if you discover that the product was not made in compliance with good manufacturing practice – a violation of FDA’s Part 820 Quality System Regulation – you must report the recall under Part 806, regardless of the health risk.
Step 2: Decide if the Action is Exempt from Part 806 Reporting
Next, decide if your potential action meets any of the three reporting exemptions defined by Part 806.2:
- Routine servicing
- Stock recovery operation
- Market withdrawal
Exercise extreme caution here, because FDA interprets these exemptions very narrowly and thinks that industry widely misinterprets (and even abuses) them. The truth is, when you review FDA’s inspection findings, you often find that the Agency’s jaundiced view is correct.
Take, for example, the concept of routine servicing. You can’t retroactively define what constitutes routine servicing after you take the recall action. You can’t say, “From now on, we’re going to do routine servicing that is going to cover this problem.” FDA considers that approach part of a corrective action taken after the recall, so the initial action is not exempt and is reportable under Part 806.
If you decide that your recall meets an 806 exemption, be sure to document your decision, including the specific exemption that applies. If your action doesn’t qualify for an exemption, move on to Step 3.
Step 3: Decide if You Should Report the Action to FDA
Ask yourself: “Is my action intended to reduce a risk to health or otherwise mitigate the potential for any adverse health consequences?” If the answer is yes, report the action.
You might find that it’s easier to make reporting decisions by taking the converse view. The only time an action’s not reportable under 806 is when there’s absolutely no potential for adverse health consequences. That means your action is intended solely to improve device performance or quality. Most recall actions won’t escape this broad regulatory net.
But if you decide you don’t have to report the recall, you must still document it. The regulation is clear: if the correction or removal is not required to be reported under Part 806.10, you must still generate the records listed in 806.20, including recall communications, effectiveness checks and field actions. Quite often, those records are the ones FDA looks at first to determine how compliant you are.
Step 4: Develop, Implement and Communicate a Recall Strategy
Once you decide that the recall should be reported under Part 806, then – and only then – turn your attention to Part 7’s general recall guidance, including such issues as the recall classification. As part of this step, you should develop a strategy for the recall. Determine its extent and depth: is it going all the way out to the individual customer? And is your individual customer a healthcare professional or the actual patient?
Then, under Part 806.10 (c), prepare and submit a Report of Correction or Removal to FDA within ten business days of initiating the action. After reporting, submit periodic (usually monthly) status reports to FDA indicating the progress of your recall and your ability to measure the effectiveness of the actions. Again, document your actions, including all communications related to the recall.
Recognize that the recall will be terminated only when FDA decides so. When you believe you’ve done all you can – and have full documentation to back up that belief – ask FDA to terminate the recall. Know that until FDA makes its final decision, your recall remains open. Consequently, your recall strategy should include frequent and sufficient communication with the Agency to help it come to a quicker, fully informed decision to end the recall.
Consequences of Non-Compliance
Keep in mind that this four-step process can’t cover every possible recall scenario or contingency, so use it as a guideline, not a set-in-stone template.
But the basic steps should help minimize over-reporting (for example, not taking advantage of the 806 exemptions) or under-reporting (focusing only on Part 7’s general rules or taking a too-narrow approach to determining health risks).
If you stumble over the Part 7 and 806 rules, or try to short-cut the decision process, the consequence could be an FDA Warning Letter or worse. Failure to report a reportable action under 806 makes your products misbranded in FDA’s eyes. As a result, the Agency likely will take – to the detriment of your customers, shareholders and product reputation – highly visible legal action against you.
Mr. Browning, President and Co-Founder of EduQuest, served as an expert field investigator and Special Assistant to the Associate Commissioner for Regulatory Affairs during his 22-year career at FDA. EduQuest can be reached by email.
