Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

​I've helped firms remediate FDA 483s and Warning Letters many times that involved failure to submit MDRs.  In all instances, the FDA required the lapsed reports to be submitted retrospectively nonetheless.

Remember that one of the fundamental reasons MDRs are required is so that FDA (a guardian of U.S. public health) can have an accurate understanding of a marketed device's true risk profile.  Accordingly, even if MDRs are submitted late, it still ultimately improves FDA's understanding of the device's risk profile. So for this topic, FDA seems to have adopted the old adage "better late than never", as FDA would choose to have a better grasp of a device's risk profile later rather than not at all.

However, to avoid embarking on a retrospective MDR effort unaware and unprepared, remember that failure to submit MDRs is one of the triggers that causes FDA to consider a Warning Letter.  Specifically, FDA district offices are instructed to consider a Warning Letter if the firm fails to:

• Report, within five workdays, after becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.
• Submit an MDR death report.
• Submit an MDR serious injury report.
• Submit an MDR malfunction report (CDRH review/concurrence generally required for these)
• Fails to develop, maintain and implement written MDR procedures.

But also remember that one of FDA's prime goals is to achieve voluntary compliance.  And an FDA Warning Letter is, by FDA procedure, principally aimed at achieving voluntary compliance so that FDA doesn't have to resort to more formal (i.e., legal) enforcement gestures.

Therefore, although it may seem that FDA wants to be tough on firms, FDA policy generally instead prefers that firms be responsible and take the appropriate actions without FDA forcing the issue. If a firm voluntarily does the right thing [such as, but not limited to, systemically submitting retrospective MDRs; assuring that the corresponding device problems / user error is sufficiently understood, bounded, and contained (up to and including recall); retrospectively supplementing / redoing associated complaint evaluations/investigations as needed, and opening a CAPA(s) to prevent recurrence of these issues], then the firm will have taken the actions required by applicable regulations such as 21 CFR 820.  In so doing, the firm will have achieved voluntary compliance.  A firm's voluntary compliance is a key factor that, by procedure, allows FDA to de-escalate and decide not to issue the Warning Letter.  Though FDA may do so nonetheless for high-profile firms, or to send a message, I believe those scenarios are the exception, not the norm.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

This message was posted by a user wishing to remain anonymous

​Thanks Kevin for your feedback,

What do I need to mention on the report for the delay in reporting ?

Thanks
Original Message:
Sent: 05-Jan-2018 15:27
From: Kevin Randall
Subject: Non Reporting of medical device adverse event

​I've helped firms remediate FDA 483s and Warning Letters many times that involved failure to submit MDRs.  In all instances, the FDA required the lapsed reports to be submitted retrospectively nonetheless.

Remember that one of the fundamental reasons MDRs are required is so that FDA (a guardian of U.S. public health) can have an accurate understanding of a marketed device's true risk profile.  Accordingly, even if MDRs are submitted late, it still ultimately improves FDA's understanding of the device's risk profile. So for this topic, FDA seems to have adopted the old adage "better late than never", as FDA would choose to have a better grasp of a device's risk profile later rather than not at all.

However, to avoid embarking on a retrospective MDR effort unaware and unprepared, remember that failure to submit MDRs is one of the triggers that causes FDA to consider a Warning Letter.  Specifically, FDA district offices are instructed to consider a Warning Letter if the firm fails to:

• Report, within five workdays, after becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.
• Submit an MDR death report.
• Submit an MDR serious injury report.
• Submit an MDR malfunction report (CDRH review/concurrence generally required for these)
• Fails to develop, maintain and implement written MDR procedures.

But also remember that one of FDA's prime goals is to achieve voluntary compliance.  And an FDA Warning Letter is, by FDA procedure, principally aimed at achieving voluntary compliance so that FDA doesn't have to resort to more formal (i.e., legal) enforcement gestures.

Therefore, although it may seem that FDA wants to be tough on firms, FDA policy generally instead prefers that firms be responsible and take the appropriate actions without FDA forcing the issue. If a firm voluntarily does the right thing [such as, but not limited to, systemically submitting retrospective MDRs; assuring that the corresponding device problems / user error is sufficiently understood, bounded, and contained (up to and including recall); retrospectively supplementing / redoing associated complaint evaluations/investigations as needed, and opening a CAPA(s) to prevent recurrence of these issues], then the firm will have taken the actions required by applicable regulations such as 21 CFR 820.  In so doing, the firm will have achieved voluntary compliance.  A firm's voluntary compliance is a key factor that, by procedure, allows FDA to de-escalate and decide not to issue the Warning Letter.  Though FDA may do so nonetheless for high-profile firms, or to send a message, I believe those scenarios are the exception, not the norm.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

Every firm's retrospective MDR scenario is different.  Factors such as, but not limited to, the firm's size, the nature and complexity of the devices, the number of overdue MDRs, and the firm's prior FDA compliance history must all be carefully considered as part of the retrospective MDR strategy.  Therefore, the advice offered below is not intended to be definitive instruction for any particular firm or scenario; it is instead intended to be general guidance for any firm's general consideration.

When retrospectively submitting late MDRs, firm's should consider using Section H (entitled "DEVICE MANUFACTURERS ONLY"), and item 10 therein (entitled "Additional Manufacturer Narrative") of the eMDR MedWatch Form 3500A to provide a careful explanation of the retrospective submission.

If the overall retrospective MDR effort is extensive, or if the subject devices are on the higher end of the risk spectrum, then the firm should also consider proactive correspondence with FDA's CDRH Division of Postmarket Surveillance (DPS), Office of Surveillance and Biometrics (OSB).  They are the ones who receive and review the implications of MDR-related events. Isaac Chang, Ph.D., is the Division Director and would be the one I would first contact if I was going to initiate such dialogue.

Such a proactive gesture will certainly be out of the ordinary. But based on my prior explanations, rationale, and corresponding experience, the FDA typically has a more favorable view of a firm who proactively does the right thing as compared to a firm where FDA discovers the issues itself before the firm does.  And remember that a significant retrospective MDR effort could likely trigger an FDA inspection of the reporting firm, so such firms should be ready for that inevitability.  But I feel it is only a matter of time before such a firm will be in that kind of territory with FDA anyway, as such scenarios have a funny way of eventually getting discovered by FDA (such as from marketplace feedback). For example, one of my clients routinely has clinicians/customers submit MedWatch Form 3500 to FDA to report concerns. And then the FDA compares that marketplace data to the Form 3500A's submitted (or missing) from the firm.  If there is a discrepancy, then FDA will take action.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Jan-2018 01:39
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Thanks Kevin for your feedback,

What do I need to mention on the report for the delay in reporting ?

Thanks
Original Message:
Sent: 05-Jan-2018 15:27
From: Kevin Randall
Subject: Non Reporting of medical device adverse event

​I've helped firms remediate FDA 483s and Warning Letters many times that involved failure to submit MDRs.  In all instances, the FDA required the lapsed reports to be submitted retrospectively nonetheless.

Remember that one of the fundamental reasons MDRs are required is so that FDA (a guardian of U.S. public health) can have an accurate understanding of a marketed device's true risk profile.  Accordingly, even if MDRs are submitted late, it still ultimately improves FDA's understanding of the device's risk profile. So for this topic, FDA seems to have adopted the old adage "better late than never", as FDA would choose to have a better grasp of a device's risk profile later rather than not at all.

However, to avoid embarking on a retrospective MDR effort unaware and unprepared, remember that failure to submit MDRs is one of the triggers that causes FDA to consider a Warning Letter.  Specifically, FDA district offices are instructed to consider a Warning Letter if the firm fails to:

• Report, within five workdays, after becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.
• Submit an MDR death report.
• Submit an MDR serious injury report.
• Submit an MDR malfunction report (CDRH review/concurrence generally required for these)
• Fails to develop, maintain and implement written MDR procedures.

But also remember that one of FDA's prime goals is to achieve voluntary compliance.  And an FDA Warning Letter is, by FDA procedure, principally aimed at achieving voluntary compliance so that FDA doesn't have to resort to more formal (i.e., legal) enforcement gestures.

Therefore, although it may seem that FDA wants to be tough on firms, FDA policy generally instead prefers that firms be responsible and take the appropriate actions without FDA forcing the issue. If a firm voluntarily does the right thing [such as, but not limited to, systemically submitting retrospective MDRs; assuring that the corresponding device problems / user error is sufficiently understood, bounded, and contained (up to and including recall); retrospectively supplementing / redoing associated complaint evaluations/investigations as needed, and opening a CAPA(s) to prevent recurrence of these issues], then the firm will have taken the actions required by applicable regulations such as 21 CFR 820.  In so doing, the firm will have achieved voluntary compliance.  A firm's voluntary compliance is a key factor that, by procedure, allows FDA to de-escalate and decide not to issue the Warning Letter.  Though FDA may do so nonetheless for high-profile firms, or to send a message, I believe those scenarios are the exception, not the norm.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

​
I agree with Kevin's take on this, and believe it is unlikely FDA would issue a warning letter for a single late MDR filing.  On the other hand, it's possible that a late MDR could trigger an inspection, or (perhaps more likely) a response to the filing asking why it was late.

Not only because of these risks, but also because the occurrence will be visible during any future inspection (and as part of good QSR practices), you may want to consider conducting a quality audit of your complaint handling system to determine whether any corrective action is needed.

------------------------------
Theodore Heise PhD RAC
VP Regulatory Scientific Affairs
MED Institute
West Lafayette IN
United States
------------------------------

Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

My recommendation is that you take appropriate action and document it in the context of the QMS, using the terminology.

 

You have a detected non-conformity: Failure to file an MDR within the required time frame.

 

First, conduct a correction. File the MDR. Ensure it is correct when you file, so you don't compound the problem.

 

Second, determine if there are other corrections to be made. Review your complaint files for reportable events that were not reported. If you cannot review all complaints since the founding of your company, then bound the review. Is there some event, such a change in procedure or a new person that might have resulted in the problem? If so, that is a natural bound. If not, consider a time bound. Since the event was 18 months ago, the review should double it at least 36 months. (This is my rule of thumb.) However if you find problems older than 18 months, then you will need to change the bound.

 

Third, initiate corrective action to understand the causes of the problem and prevent recurrence. Be sure to follow 820.100. You don't want a 483 observation for an incorrect corrective action.

 

My belief is that if you do a thorough job, document the work, and provide the rationale for any decision making, then you will avoid a Warning Letter. You may even avoid a 483 observation.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

Dear A:

Your post caught my attention with few reasons. 

You state "If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago."

My suggestion would be to best use the applicable regulations for your event to re-determine whether it is reportable or not.

Please note: not all user errors are reportable. To be reportable as an MDR, it should meet the reporting requirements (e.g., cause or association with death or serious injury, likely to cause death or serious injury if the event recurred). 

For the past 18 months, has your firm received similar or the same user error? If not received, you may be in a position to justify (no need to report per se) BECAUSE the event wouldn't be likely to cause or contribute to death or serious injury as the probability of recurrence is minimized (remote). If received and it meets the reporting requrements, please consider reporting it now!!!

If you want to be conservative, you may choose to report all user errors within timeline or even if it is late.

Please make sure the following procedures under check.

1. Complaint handling
2. Risk management process
3. MDR
4. CAPA
5. Services
etc. ​

------------------------------
Dr. David Lim, Ph.D., RAC, ASQ-CQA
President and CEO | REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US
------------------------------

Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

This message was posted by a user wishing to remain anonymous

It is not clear that the MDR Medwatch form is required for AEs during clinical trials for pre-market devices under an IDE. 
These events are communicated under IDE annual reporting, do they also need to be reported under MEDWATCH?
Any advice?
Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

MDRs only apply to products that are legally marketed in the US.  If the product is under an IDE AND also legally marketed, it can get a bit more complex.  Take a look here for some FAQs on that topic:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051480.htm

Cheers,
Melissa

------------------------------
Melissa Walker RAC
President & CTO
St Louis MO
United States
------------------------------

Original Message:
Sent: 23-May-2018 11:14
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

It is not clear that the MDR Medwatch form is required for AEs during clinical trials for pre-market devices under an IDE.
These events are communicated under IDE annual reporting, do they also need to be reported under MEDWATCH?
Any advice?
Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,

Interestingly I just attended a local REDi conference (FDA Regulatory Education for Industry (REdI) Spring, May 15-16, 2018) and this question came up.  Contrary to the link/information which details the following:



------------------------------
Peggy McLaughlin
United States
------------------------------

Original Message:
Sent: 24-May-2018 08:04
From: Melissa Walker
Subject: Non Reporting of medical device adverse event

MDRs only apply to products that are legally marketed in the US.  If the product is under an IDE AND also legally marketed, it can get a bit more complex.  Take a look here for some FAQs on that topic:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051480.htm

Cheers,
Melissa

------------------------------
Melissa Walker RAC
President & CTO
St Louis MO
United States

Original Message:
Sent: 23-May-2018 11:14
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

It is not clear that the MDR Medwatch form is required for AEs during clinical trials for pre-market devices under an IDE.
These events are communicated under IDE annual reporting, do they also need to be reported under MEDWATCH?
Any advice?
Original Message:
Sent: 04-Jan-2018 22:04
From: Anonymous Member
Subject: Non Reporting of medical device adverse event

This message was posted by a user wishing to remain anonymous

​Hi ,

If an adverse event which was actually reportable ( occurred due to user error and wasn't due to device fault) but wasn't reported to the FDA , what can be done now ?It occurred almost 18 months ago. Is there any we can do the reporting now ?

Thanks,