The issue is, unfortunately, complicated by the lack of clear criteria.
I tend to be picky over language, so forgive me. I don’t mean to offend, only clarify. You contrast “recall due to violation” and “withdrawal due to minor violation”. In dealing with C&R, remove the word recall from your vocabulary (and mind). In the context of a field action, the question is reportability under Part 806. In Part 806 the action is either a correction or a removal, not a withdrawal. Market Withdrawal is a reporting exception.
The criteria is, unfortunately, whether or not the field action is a Market Withdrawal. The definition in 806.3(i) is “a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices”.
You, as the manufacturer must decide if the violation is one where FDA would take legal action. This is, at best, a quagmire. A manufacturer must evaluate any potential action by FDA. On the other hand, I’ve never seen a Warning Letter because the manufacturer classified a field action as a “minor violation”.
My test, albeit subjective, assumes that a 483 constitutes legal action. If you had a problem, did not address it, and it came to the attention of an Investigator during an Inspection, would you expect a 483? If so, then it is not a market withdrawal and is reportable. Many would set the bar higher, and I believe the guidance document uses a higher threshold, but doesn’t offer an explanation.
FDA has a hierarchy of actions ranging from 483 to Consent Decree to Civil Money Penalties, etc. I tend to advise companies to set the bar low, believing that over reporting under Part 806 is better than risking a 483 and the subsequent Warning Letter.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 10-02-2015 14:29
From: Kathy Mills
Subject: Recall vs. Market Withdrawal
Thanks, Dan. That was a great explanation.
But when do you know you're performing a recall due to a "violation" vs. a withdrawal due to a "minor violation?" You used the example of an incorrect address which falls under mislabeling as a "minor" violation. But what is the criteria? What if the label has the wrong product or batch code? And what other violations (other than mislabeling) are considered "minor?"
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Kathy Mills
United States
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Original Message:
Sent: 10-02-2015 13:10
From: Dan O'Leary
Subject: Recall vs. Market Withdrawal
One of the things that makes this complicated is that there are two different process performed by two different organizations, but the processes intersect. The best approach is to separate them. You as the device manufacturer are responsible for the Corrections and Removals process under Part 806. The FDA is responsible for the Recall process under Part 7. You, as the device manufacturer, do not classify the recall, FDA does that.
Part 806 and Part 7 use many of the same terms which are defined in their respective parts. Unfortunately, the definitions are close, but not the same.
There is a recent CDRH guidance document on distinguishing product enhancements from recalls. It clarifies much of this, significantly improves the draft version, but, in my opinion, doesn’t get to the heart of the matter, implementing Part 806.
Whenever you modify a device that has been released for distribution [(820.80(d)] you should classify the reason as a) reduce a risk to health, b) remedy a violation, or c) product enhancement. Similarly, classify every design change [(820.30(i)] using the same criteria.
Violations include failure to meet a published performance characteristic, i.e., the device doesn’t perform as expected, it was not properly cleared, etc. If the design change falls into a) or b), then you should start the C&R process.
The C&R process requires notification to FDA under 806.10, but there are exceptions: a) enhancements, b) market withdrawals, c) routine servicing, and d) stock recoveries. These are all technical terms, so a carful reading of the definitions is required. If one of the exceptions apply, then you don’t report, but keep a record of why not under 806.20.
When FDA receives the report, they will initiate Part 7 process, classify the recall, and involve you in the recall process.
To answer your last question, the draft guidance document uses an example of an incorrect address on a device label. The manufacturer sends out a sticker to cover the address with the correct one. The violation is mislabeling, but it is a minor violation and probably doesn’t need to be reported because it is a Market Withdrawal, “a minor violation of the act that would not be subject to legal action by FDA”.
Part 7 applies to all products FDA regulates, but Part 806 only applies to devices. The way Part 806 is set up, the expectation is that FDA would classify each C&R report as a Class I or Class II recall only.
To stop going in circles, don’t try to classify the recall as part of your decision making process. Effectively implement Part 806 and the rest will follow.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 10-02-2015 12:10
From: Kathy Mills
Subject: Recall vs. Market Withdrawal
I'm going 'round in circles in my mind regarding corrections and removals and hoping y'all can help.
A "recall" involves removal of a device "in violation of the laws." And a "Class III Recall" is "not likely to cause adverse health consequences."
But part of the definition of "withdrawal" involves a "minor violation of the act."
So when can I call a removal or correction a withdrawal because it is a minor violation (what would be an example of "minor") vs. calling it a class III recall because the device isn't likely to pose any risk to health?
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Kathy Mills
United States
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