Regulatory Open Forum

1. Are there timelines as to in how many days manufacturers have to perform a recall? Are there due dates that needs to be met per the regulation for recall notification to both the FDA and  customer (consignee)?
2. I see that per 21 CFR 806.10(d) does require manufacturers to submit to the FDA within 10-working days.

1. Are there timelines as to in how many days manufacturers have to perform a recall? Are there due dates that needs to be met per the regulation for recall notification to both the FDA and  customer (consignee)?
2. I see that per 21 CFR 806.10(d) does require manufacturers to submit to the FDA within 10-working days.

1. Are there timelines as to in how many days manufacturers have to perform a recall? Are there due dates that needs to be met per the regulation for recall notification to both the FDA and  customer (consignee)?
2. I see that per 21 CFR 806.10(d) does require manufacturers to submit to the FDA within 10-working days.

It is important to distinguish between Corrections & Removals in Part 806 and recalls in Part 7.

When your company decides to inform customer of the need for a correction or removal (C&R), then the Part 806 10-day clock starts to inform FDA. While the regulations don't specify a time to notify customers, don't delay. Your notifications should have gone out within the same 10-day window.

Similarly, there is no timeline to receive notification that the customer has completed the action. If FDA classifies the C&R as a recall under Part 7 they will ask you for a recall plan with timing, depth of recall, etc.

1. Are there timelines as to in how many days manufacturers have to perform a recall? Are there due dates that needs to be met per the regulation for recall notification to both the FDA and  customer (consignee)?
2. I see that per 21 CFR 806.10(d) does require manufacturers to submit to the FDA within 10-working days.

Thank you all for the response!

Hi Dan,

My understanding is that, if a manufacturer becomes aware of any issue, then they start the correction and removal as stated in Part 806. Notify FDA within 10-working days with the listed content on Section 806.10 (c) 1 – 13. FDA can always issue a recall based on the information submitted per 810?

Also, if manufacturer decides that a recall is required. Then a voluntary recall is initiated per CFR 7. A recall strategy (sec 7.42) is drafted by the manufacturer and sent to FDA. A recall is initiated when the FDA is reviewing or even before. When drafting a recall strategy, it does mention that "result of health hazard evaluation" is to be taken into consideration, I thought that the HHE is performed by FDA and not by the manufacturer, is my assumption correct? If that is the case, what does the Manufacturer need to include in a recall strategy.

I am also slightly confused as to what is the difference between "correction and removal" and "recall" aren't they considered the same?

Thank you in advance!

It is important to distinguish between Corrections & Removals in Part 806 and recalls in Part 7.

When your company decides to inform customer of the need for a correction or removal (C&R), then the Part 806 10-day clock starts to inform FDA. While the regulations don't specify a time to notify customers, don't delay. Your notifications should have gone out within the same 10-day window.

Similarly, there is no timeline to receive notification that the customer has completed the action. If FDA classifies the C&R as a recall under Part 7 they will ask you for a recall plan with timing, depth of recall, etc.

1. Are there timelines as to in how many days manufacturers have to perform a recall? Are there due dates that needs to be met per the regulation for recall notification to both the FDA and  customer (consignee)?
2. I see that per 21 CFR 806.10(d) does require manufacturers to submit to the FDA within 10-working days.

There is a particular process to follow. First, Part 806 is for devices only and the manufacturer implements it. Part 7 is for all FDA regulated products and FDA implements it. Part 806 may feed information to Part 7.

Start by deciding whether your company has a device issue about which you should inform your customers. Determine what the customer' actions and inform them. Send the information to, at least, the initial consignees using the data from 820.160(b) without "undue haste". (In ISO 13485:2016 this is an advisory notice.)

Determine if the issue is exempt from reporting by using 806.1(b). In addition, there is another exemption in the post-market cybersecurity document.

If it is exempt from reporting, produce the 806.20 documentation as quality records. You do not have to report to FDA that the issue is exempt from reporting. STOP.

If it is not exempt from reporting determine if it is a correction, a removal, or both using the definitions in 806(2). An issue could both depending on who implements the action. A Field Service Rep may handle some customers on site (correction) while other customers need to send the device to another location for implementation (removal). This distinction determines the format of the report numbers.

Submit the reports using eSubmitter.

FDA will determine whether the report is a recall and its class. They will also tell you things like the depth of the recall and the effectiveness. You will prepare a recall plan and submit it to FDA.

The important thing is the manufacturer does not decide if the action is a recall. FDA makes that decision based on the information submitted under 806.10.

FDA conducts the HHE to help make the decision on whether the action is a recall and its class. The HHE helps guide the manufacturer's recall strategy for things like the depth of the recall and the effectiveness check.

Many people use the term "correction and removal" as well the term "recall" as synonyms.

Compare the definition of correction in Part 7 with the definition in Part 806.

Compare the definition of removal in Part 7 with the definition in Part 806.

Read the definition of recall in Part 7 and notice that the term is not in Part 806.

Thank you all for the response!

Hi Dan,

My understanding is that, if a manufacturer becomes aware of any issue, then they start the correction and removal as stated in Part 806. Notify FDA within 10-working days with the listed content on Section 806.10 (c) 1 – 13. FDA can always issue a recall based on the information submitted per 810?

Also, if manufacturer decides that a recall is required. Then a voluntary recall is initiated per CFR 7. A recall strategy (sec 7.42) is drafted by the manufacturer and sent to FDA. A recall is initiated when the FDA is reviewing or even before. When drafting a recall strategy, it does mention that "result of health hazard evaluation" is to be taken into consideration, I thought that the HHE is performed by FDA and not by the manufacturer, is my assumption correct? If that is the case, what does the Manufacturer need to include in a recall strategy.

I am also slightly confused as to what is the difference between "correction and removal" and "recall" aren't they considered the same?

Thank you in advance!

It is important to distinguish between Corrections & Removals in Part 806 and recalls in Part 7.

When your company decides to inform customer of the need for a correction or removal (C&R), then the Part 806 10-day clock starts to inform FDA. While the regulations don't specify a time to notify customers, don't delay. Your notifications should have gone out within the same 10-day window.

Similarly, there is no timeline to receive notification that the customer has completed the action. If FDA classifies the C&R as a recall under Part 7 they will ask you for a recall plan with timing, depth of recall, etc.

1. Are there timelines as to in how many days manufacturers have to perform a recall? Are there due dates that needs to be met per the regulation for recall notification to both the FDA and  customer (consignee)?
2. I see that per 21 CFR 806.10(d) does require manufacturers to submit to the FDA within 10-working days.

There is a particular process to follow. First, Part 806 is for devices only and the manufacturer implements it. Part 7 is for all FDA regulated products and FDA implements it. Part 806 may feed information to Part 7.

Start by deciding whether your company has a device issue about which you should inform your customers. Determine what the customer' actions and inform them. Send the information to, at least, the initial consignees using the data from 820.160(b) without "undue haste". (In ISO 13485:2016 this is an advisory notice.)

Determine if the issue is exempt from reporting by using 806.1(b). In addition, there is another exemption in the post-market cybersecurity document.

If it is exempt from reporting, produce the 806.20 documentation as quality records. You do not have to report to FDA that the issue is exempt from reporting. STOP.

If it is not exempt from reporting determine if it is a correction, a removal, or both using the definitions in 806(2). An issue could both depending on who implements the action. A Field Service Rep may handle some customers on site (correction) while other customers need to send the device to another location for implementation (removal). This distinction determines the format of the report numbers.

Submit the reports using eSubmitter.

FDA will determine whether the report is a recall and its class. They will also tell you things like the depth of the recall and the effectiveness. You will prepare a recall plan and submit it to FDA.

The important thing is the manufacturer does not decide if the action is a recall. FDA makes that decision based on the information submitted under 806.10.

FDA conducts the HHE to help make the decision on whether the action is a recall and its class. The HHE helps guide the manufacturer's recall strategy for things like the depth of the recall and the effectiveness check.

Many people use the term "correction and removal" as well the term "recall" as synonyms.

Compare the definition of correction in Part 7 with the definition in Part 806.

Compare the definition of removal in Part 7 with the definition in Part 806.

Read the definition of recall in Part 7 and notice that the term is not in Part 806.

Thank you all for the response!

Hi Dan,

My understanding is that, if a manufacturer becomes aware of any issue, then they start the correction and removal as stated in Part 806. Notify FDA within 10-working days with the listed content on Section 806.10 (c) 1 – 13. FDA can always issue a recall based on the information submitted per 810?

Also, if manufacturer decides that a recall is required. Then a voluntary recall is initiated per CFR 7. A recall strategy (sec 7.42) is drafted by the manufacturer and sent to FDA. A recall is initiated when the FDA is reviewing or even before. When drafting a recall strategy, it does mention that "result of health hazard evaluation" is to be taken into consideration, I thought that the HHE is performed by FDA and not by the manufacturer, is my assumption correct? If that is the case, what does the Manufacturer need to include in a recall strategy.

I am also slightly confused as to what is the difference between "correction and removal" and "recall" aren't they considered the same?

Thank you in advance!

It is important to distinguish between Corrections & Removals in Part 806 and recalls in Part 7.

When your company decides to inform customer of the need for a correction or removal (C&R), then the Part 806 10-day clock starts to inform FDA. While the regulations don't specify a time to notify customers, don't delay. Your notifications should have gone out within the same 10-day window.

Similarly, there is no timeline to receive notification that the customer has completed the action. If FDA classifies the C&R as a recall under Part 7 they will ask you for a recall plan with timing, depth of recall, etc.

1. Are there timelines as to in how many days manufacturers have to perform a recall? Are there due dates that needs to be met per the regulation for recall notification to both the FDA and  customer (consignee)?
2. I see that per 21 CFR 806.10(d) does require manufacturers to submit to the FDA within 10-working days.