Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

If a manufacturer erroneously submits a Medwatch form to FDA, is there a process to amend, rescind, or reverse this? If so, is there a resource that details this? If there isn't a resource, can you provide a quick summary of what is done?

Thank you so much!

File a supplement to explain the situation.

Be sure to document the decision in the 820.198 investigation and in the 803.18 MDR Event File.

Consider the April 22, 2008 Warning Letter to Care Rehab and Orthopaedic Products, Inc.
We have reviewed your response for the complaint dated 2/2007 and listed as part of Observation 2 on the FDA-483. Your investigation into the injury revealed that the patient did not suffer a serious injury as first reported to your firm. You determined that, since an injury did not actually occur, you did not need to file an MDR with the agency. We have concluded that your response is inadequate because you made the decision not to file an MDR based on information received from the patient negating a claim of a serious injury, however you did not document this decision in your MDR event file.

 

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 27-May-2020 14:24
From: Anonymous Member
Subject: MEDWATCH/MEDICAL DEVICE REPORTING

This message was posted by a user wishing to remain anonymous

If a manufacturer erroneously submits a Medwatch form to FDA, is there a process to amend, rescind, or reverse this? If so, is there a resource that details this? If there isn't a resource, can you provide a quick summary of what is done?

Thank you so much!

Hello,

US FDA Medical Device Reports (MDR) once put in the database are not really taken out or deleted.  What you probably need to do is log-in to the FDA MAUDE database, go to the record and write a follow-up response this was done in error, not valid, not your product, etc.  I am not sure there is a specific resource detailing how to do something like this, but the MDR instructions may provide some information.in this specific case, but as far as I know there is no option to "delete" a record.  The US FDA is quite helpful, so you can contact them directly to see if there is a way to remove the record if truly done in error.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 27-May-2020 17:03
From: Dan O'Leary
Subject: MEDWATCH/MEDICAL DEVICE REPORTING

File a supplement to explain the situation.

Be sure to document the decision in the 820.198 investigation and in the 803.18 MDR Event File.

Consider the April 22, 2008 Warning Letter to Care Rehab and Orthopaedic Products, Inc.
We have reviewed your response for the complaint dated 2/2007 and listed as part of Observation 2 on the FDA-483. Your investigation into the injury revealed that the patient did not suffer a serious injury as first reported to your firm. You determined that, since an injury did not actually occur, you did not need to file an MDR with the agency. We have concluded that your response is inadequate because you made the decision not to file an MDR based on information received from the patient negating a claim of a serious injury, however you did not document this decision in your MDR event file.

 

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 27-May-2020 14:24
From: Anonymous Member
Subject: MEDWATCH/MEDICAL DEVICE REPORTING

This message was posted by a user wishing to remain anonymous

If a manufacturer erroneously submits a Medwatch form to FDA, is there a process to amend, rescind, or reverse this? If so, is there a resource that details this? If there isn't a resource, can you provide a quick summary of what is done?

Thank you so much!