Regulatory Open Forum

We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?

FDA's internal operating procedures are that FDA should terminate the recall within three months after the firm completes the recall. But there are a number of things that generally happen in the background that may be delaying the recall termination.  Here are some thoughts:

• FDA's general standard operating procedure is to notify the recalling firm via official letter stating that FDA considers the recall terminated. Thus, FDA's public database is not the best way to be apprised of your recall termination.

• FDA generally advises the recalling firm that FDA will not terminate a recall until the firm has brought the product into compliance or disposed of it in an acceptable manner. Accordingly, delays in recall termination may be an indication that FDA doesn't believe that the recalling firm did a sufficient job with the recall.

• The classification of your recall will also affect FDA's termination proceedings. For example,

• • Class I recalls require Center concurrence and thus may be delayed purely for logistical reasons.
  • Class I, some Class II recalls, may require an establishment inspection before FDA will terminate the recall. FDA's tactics and timing about such an inspection and FDA's responsiveness to interim inquiries about status could be strategically affected (i.e., delayed, hidden, etc.) in order to assure that FDA gets the most authentic exposure to the recalling firm.

• FDA might simply be backlogged for lack of resources. If FDA told you that you were in the queue for termination, that might mean there is simply a backlog and that FDA has already decided your case is a good candidate for termination; or that might mean FDA has made no conclusion about candidacy and hasn't actually scrutinized the recall results data at all.

Should you contact FDA again for a status update? Each firm's (i.e., the CEO's) quality culture and attitude will have an impact on that. Thus, no one can answer this question for your case but your firm.

My personal approach with our clients is that gestures and overtures showing the firm's commitment to compliance generally always pays positive compliance dividends. Being proactive and contacting FDA to discuss recall status is an example of this. Yet some philosophies are to leave a sleeping giant alone. Both philosophies have their own merits.

We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?

Thanks so much for the thorough reply! Perhaps I will urge us to follow up then. My philosophy tends to be similar to yours when it comes to proactive compliance.

FDA's internal operating procedures are that FDA should terminate the recall within three months after the firm completes the recall. But there are a number of things that generally happen in the background that may be delaying the recall termination.  Here are some thoughts:

• FDA's general standard operating procedure is to notify the recalling firm via official letter stating that FDA considers the recall terminated. Thus, FDA's public database is not the best way to be apprised of your recall termination.

• FDA generally advises the recalling firm that FDA will not terminate a recall until the firm has brought the product into compliance or disposed of it in an acceptable manner. Accordingly, delays in recall termination may be an indication that FDA doesn't believe that the recalling firm did a sufficient job with the recall.

• The classification of your recall will also affect FDA's termination proceedings. For example,

• • Class I recalls require Center concurrence and thus may be delayed purely for logistical reasons.
  • Class I, some Class II recalls, may require an establishment inspection before FDA will terminate the recall. FDA's tactics and timing about such an inspection and FDA's responsiveness to interim inquiries about status could be strategically affected (i.e., delayed, hidden, etc.) in order to assure that FDA gets the most authentic exposure to the recalling firm.

• FDA might simply be backlogged for lack of resources. If FDA told you that you were in the queue for termination, that might mean there is simply a backlog and that FDA has already decided your case is a good candidate for termination; or that might mean FDA has made no conclusion about candidacy and hasn't actually scrutinized the recall results data at all.

Should you contact FDA again for a status update? Each firm's (i.e., the CEO's) quality culture and attitude will have an impact on that. Thus, no one can answer this question for your case but your firm.

My personal approach with our clients is that gestures and overtures showing the firm's commitment to compliance generally always pays positive compliance dividends. Being proactive and contacting FDA to discuss recall status is an example of this. Yet some philosophies are to leave a sleeping giant alone. Both philosophies have their own merits.

We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?

FDA's internal operating procedures are that FDA should terminate the recall within three months after the firm completes the recall. But there are a number of things that generally happen in the background that may be delaying the recall termination.  Here are some thoughts:

• FDA's general standard operating procedure is to notify the recalling firm via official letter stating that FDA considers the recall terminated. Thus, FDA's public database is not the best way to be apprised of your recall termination.

• FDA generally advises the recalling firm that FDA will not terminate a recall until the firm has brought the product into compliance or disposed of it in an acceptable manner. Accordingly, delays in recall termination may be an indication that FDA doesn't believe that the recalling firm did a sufficient job with the recall.

• The classification of your recall will also affect FDA's termination proceedings. For example,

• • Class I recalls require Center concurrence and thus may be delayed purely for logistical reasons.
  • Class I, some Class II recalls, may require an establishment inspection before FDA will terminate the recall. FDA's tactics and timing about such an inspection and FDA's responsiveness to interim inquiries about status could be strategically affected (i.e., delayed, hidden, etc.) in order to assure that FDA gets the most authentic exposure to the recalling firm.

• FDA might simply be backlogged for lack of resources. If FDA told you that you were in the queue for termination, that might mean there is simply a backlog and that FDA has already decided your case is a good candidate for termination; or that might mean FDA has made no conclusion about candidacy and hasn't actually scrutinized the recall results data at all.

Should you contact FDA again for a status update? Each firm's (i.e., the CEO's) quality culture and attitude will have an impact on that. Thus, no one can answer this question for your case but your firm.

My personal approach with our clients is that gestures and overtures showing the firm's commitment to compliance generally always pays positive compliance dividends. Being proactive and contacting FDA to discuss recall status is an example of this. Yet some philosophies are to leave a sleeping giant alone. Both philosophies have their own merits.

We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?

We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?

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Kimberly Chan
X-Nav Technologies
Lansdale PA
United States
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We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?

------------------------------
Kimberly Chan
X-Nav Technologies
Lansdale PA
United States
------------------------------

We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?

My company conducted a Class 2 recall during a similar timeframe with a request for termination in spring 2023. Since then we have checked in with our recall coordinator three times and each time been informed that the recall is still in queue for termination.

We had a recall from 2022-2023. We requested closure from the FDA in April 2023, and they responded back that we were in the queue for termination. However, it looks like that recall is still open. I would love to finally put this recall to rest, especially since I don't have any more actions (except to anxiously check the FDA Recall page every so often)! They haven't contacted us asking for more information, and I feel confident that we did an excellent job with our effectiveness check. Is a 1 year long queue for termination typical? Should I reach out to someone at the FDA regarding it?