Regulatory Open Forum

Hello,

Problem: Our external manufacturer has shipped a product with wrong packaging insert. The issue is related to US shipment only but this product (Medical Device) is sold in CANADA as well. There is no issue reported to the consumers. The product was identified to be shipped with wrong packaging insert (Shipment issue only). My questions are -

1. How should be proceed with the recall with FDA? What are the list of documents needed to report to FDA? How should we initiate the recall process?

2. Should the external manufacturer notify ECRI and in what case do they notify ECRI?

3. Should the FRN for Canada has to filled out since this product is also sold in Canada? If so what is the timeline for reporting in this scenario?

Thank you!

Hello,

Problem: Our external manufacturer has shipped a product with wrong packaging insert. The issue is related to US shipment only but this product (Medical Device) is sold in CANADA as well. There is no issue reported to the consumers. The product was identified to be shipped with wrong packaging insert (Shipment issue only). My questions are -

1. How should be proceed with the recall with FDA? What are the list of documents needed to report to FDA? How should we initiate the recall process?

2. Should the external manufacturer notify ECRI and in what case do they notify ECRI?

3. Should the FRN for Canada has to filled out since this product is also sold in Canada? If so what is the timeline for reporting in this scenario?

Thank you!

For the US there are some technical distinctions that are important and could make the process easier. The manufacturer does not initiate a recall, the FDA does. Instead, the manufacturer files a Corrections and Removals report under Part 806 with FDA. FDA will review the report to determine if it is a recall under Part 7.

In this case, your strategy should identify the initial consignee from the records you kept under 820.160. Send each one a replacement package insert and tell them to discard the incorrect one.

Become familiar with Part 806 and the requirements for reporting. There is also a guidance document that will help.

Sending a replacement package insert is a correction not a removal. The distinction is important in creating the records.

Look at the definition of market withdrawal – a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA.

The guidance document has an example of an incorrect address on a package for which the manufacturer send a label to cover the incorrect address. The guidance document classified this as a market withdrawal and, therefore, not reportable.

If you report, use the module in eSubmitter. Your company should have eSubmitter installed to comply with MDR reporting under Part 806. If you don't report keep the records required by 806.20.

If you are under FDA Inspections, the FDA Investigator will check the records.

If you are under MDSAP, then the auditor will check the records as part of the advisory notice portion of the audit.

Hello,

Problem: Our external manufacturer has shipped a product with wrong packaging insert. The issue is related to US shipment only but this product (Medical Device) is sold in CANADA as well. There is no issue reported to the consumers. The product was identified to be shipped with wrong packaging insert (Shipment issue only). My questions are -

1. How should be proceed with the recall with FDA? What are the list of documents needed to report to FDA? How should we initiate the recall process?

2. Should the external manufacturer notify ECRI and in what case do they notify ECRI?

3. Should the FRN for Canada has to filled out since this product is also sold in Canada? If so what is the timeline for reporting in this scenario?

Thank you!

• Firm's absolutely do, and are expected by FDA to, initiate recalls.  In fact, firm-initiated recalls are, by an overwhelming margin, the most common way recalls start.  For example (just one of many that can be given), FDA's enforcement policy in 21 CFR Part 7 states that a recall strategy will be developed by the recalling firm "for a firm-initiated recall", and also lays out many other responsibilities for firms in firm-initiated recalls.

• To ultimately and properly (i.e., statutorily) apply FDA's recall trigger rules, you need to be applying a carefully-designed recall evaluation decision tree that, in practical/operational terms, distinguishes recalls from market withdrawals and stock recoveries.  I use such a decision tree with my clients to help with this step.  Indeed, FDA's recall trigger is a statutorily / legally-intensive threshold, the practical interpretation of which isn't always immediately clear at face value.  Specifically, a recall is required for products the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.  If one isn't fluent with how FDA has translated this nebulous trigger into practical working terms, then it will lead to unnecessary recalls, or to failing to recall when required, or to under- or over-reporting of recalls.

• A 21 CFR Part 806 report is absolutely not how firms should notify FDA of potential recalls so that the Agency can decide if the firm's action is to be a recall.  Instead, Part 806 reports are required when it is already clear that a correction or removal is being initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health.  FDA reminds us that this threshold generally tracks to Class I and Class II recalls, yet not to Class III recalls.  So, it is neither good compliance, nor good business, to mindlessly prepare and endure the Part 806 reporting process in situations where Part 806 reports aren't required, for example for market withdrawals, stock recoveries, and Class III recalls.

• FDA's eSubmitter, which many firms find difficult to set up and use, is not required for submission of Part 806 reports (if any report is required at all).  Accordingly, if you're not already set up for using FDA's eSubmitter, then the report (if any is required at all; see preceding bullets) may just be submitted via email.

For the US there are some technical distinctions that are important and could make the process easier. The manufacturer does not initiate a recall, the FDA does. Instead, the manufacturer files a Corrections and Removals report under Part 806 with FDA. FDA will review the report to determine if it is a recall under Part 7.

In this case, your strategy should identify the initial consignee from the records you kept under 820.160. Send each one a replacement package insert and tell them to discard the incorrect one.

Become familiar with Part 806 and the requirements for reporting. There is also a guidance document that will help.

Sending a replacement package insert is a correction not a removal. The distinction is important in creating the records.

Look at the definition of market withdrawal – a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA.

The guidance document has an example of an incorrect address on a package for which the manufacturer send a label to cover the incorrect address. The guidance document classified this as a market withdrawal and, therefore, not reportable.

If you report, use the module in eSubmitter. Your company should have eSubmitter installed to comply with MDR reporting under Part 806. If you don't report keep the records required by 806.20.

If you are under FDA Inspections, the FDA Investigator will check the records.

If you are under MDSAP, then the auditor will check the records as part of the advisory notice portion of the audit.

Hello,

Problem: Our external manufacturer has shipped a product with wrong packaging insert. The issue is related to US shipment only but this product (Medical Device) is sold in CANADA as well. There is no issue reported to the consumers. The product was identified to be shipped with wrong packaging insert (Shipment issue only). My questions are -

1. How should be proceed with the recall with FDA? What are the list of documents needed to report to FDA? How should we initiate the recall process?

2. Should the external manufacturer notify ECRI and in what case do they notify ECRI?

3. Should the FRN for Canada has to filled out since this product is also sold in Canada? If so what is the timeline for reporting in this scenario?

Thank you!