MDR (Medical Device Reporting) under 21 CFR Part 803

[Lerotronic]

Hi All,

Since topic on MDR reporting to FDA is lacking let's get this discussion started for all of you reporters out there.

I have a questions first actually: If the event was initialy reported to FDA via an MDR but was later deemed that the event is not an MDR reportable event, how does one cancel the previos report?

Thank you all!

 

[shimonv]

I am not aware of an option to cancel MDR. What you can do is file a follow-up report with additional information and conclusion.

-Shimon

 

[Lerotronic]

I am not aware of an option to cancel MDR. What you can do is file a follow-up report with additional information and conclusion.



-Shimon

That is my current logic as well. However I am not sure how does FDA use the data on reporting (and what paremeters are being tracked). Does anyone know if there is a difference between submitting a follow-up explaining that this is a non reportable event and in some way canceling the report?

Any additional data on how does FDA use reported data would also be highly appreciated!

Thanks,
Lero


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[shimonv]

Lets see who else joins the discussion...
I'll just add that I wouldn't be concern by just one MDR report. There are companies that submits hundreds of MDR reports annually; just look at the MDR public database.

I can only guess that what FDA is looking for is risk-based trends per medical specialty, per company. Your one 'glitch' only show abundance of caution.


Cheers,
Shimon

 

[QA-Man]

Lets see who else joins the discussion...
I'll just add that I wouldn't be concern by just one MDR report. There are companies that submits hundreds of MDR reports annually; just look at the MDR public database.

I can only guess that what FDA is looking for is risk-based trends per medical specialty, per company. Your one 'glitch' only show abundance of caution.


Cheers,
Shimon

The only time I have experienced problems with MDR's is when they weren't filed.

The only time I had a surprise inspection was when a customer sent two MedWatch forms to the FDA but we did not. Fortunately the FDA agreed with our justification for not doing so but now I would probably just sent them to avoid being on the FDA's radar.

 

[Lerotronic]

Thanks for the reply everyone! Is there any document explaining how is FDA using information provided under 803 and what kind of significance is given to what kind of trends?

More then less is also my logic when reporting, but structure and consisteny is also my high concern in order to drive quality througout the team - hence the questioning on the topic.


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