Criteria for Reportable Event vs. Adverse Event in Device Studies

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devicefordummy

#1
I work in the clinicl research depart of our company and would like to understand regulations pertainning to sponsor rather than manufactuer. I have a few questions and hopefully someone can help clarify!!


1)Does Reportable Event apply to non-significant device studies only? What are the criterias?

Does AE in device studies apply to Significant studies only?

2) Do MDRs apply to Significant studies only? I was advised by my company's regulatory that reportable events are submitted on MDRs and adverse events are submitted by the company's own AE template. Is this correct?
 
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yodon

Staff member
Moderator
#2
I could use some help in understanding your problem / question. I'm not familiar with the terms "non-significant study" and "significant study." Can you clarify?

Are you talking about marketed devices, devices in a clinical study, or prototype devices?

In general, an adverse event is reportable. So yes, reportable events are submitted on MDRs. How adverse event documentation is done internally before being submitted via MDR could certainly be using your own templates.

I don't know how the (non)significant study activities factor in.
 
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devicefordummy

#3
To clarify my questions, i mean with regards to 510k / non significant risk study, is undesirable happenings submitted as Reportable Events or as Adverse Events?

And is undesirable happenings for significant risk studies (PMA and IDE) submitted as Reportable Events or as AE?

Are the criterias for Reportable Events and AE different?
 

yodon

Staff member
Moderator
#4
I think the issue I'm having is that you're using terminology that doesn't map to the FDA definitions - at least not that I can tell.

A 510(k) and a PMA is your permission, so to speak, to legally market a device. These are paperwork exercises, basically.

Once you have a device on the market, if an "undesirable happening" occurs, you need to analyze it to determine if it constitutes a reoprtable event. The undesirable happening coule well be an adverse event (in which case, it would clearly be reportable).

So every adverse event is a reportable event. Not every reportable event is an adverse event, though. If you happen to find out that the device could blow up under some odd circumstance, that is reportable. I expect that if you click on some of the tags links, you can find a reporting decision tree (flow chart). Take a look at this thread: http://elsmar.com/Forums/showthread.php?t=24994

I don't know what the reporting requirements are for when you have an IDE. I would presume they are the same. I'm still not clear on what a "non significant risk study" is, though.
 
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devicefordummy

#5
i think i am confused on the fact that reportable event is exclusively for device studies and are suppose to be submitted in MDRs-and these are submitted to both FDA and the IRB. Since an AE in device study doesnt always constitute as a RE, should it be reported in MDRs too? Or are they submitted on Sponsor's own template?

From what I gather, a significant study typically means a PMA or IDE. Non-significant studies (which requires only IRB approval to conduct a clinical study)are 510ks(?)
 

dblnkl

Inactive Registered Visitor
#7
There are specific criteria in the regs to distinguish SR and NSR studies. But an NSR device study is a local study only, not requiring FDA approval, approved as such only by your local IRB for one site. An SR study, local or not, requires FDA approval to proceed. Adverse events during a clinical study are reportable but do not have a specific report format. SAEs are reportable during a clinical study within very specific time limits to both IRB and FDA (time limits may well be different). SAEs, by definition, are serious and require very specific analysis and follow-through. AEs during a clinical study can be reported along with your next normal periodic reporting or separately, as you wish. AEs/SAEs are reported through MDR once the product has received marketing approval by the FDA.
 
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devicefordummy

#8
What if the product has not recieve marketing approval from the FDA? Would the AE/SAE still be reported through MDR?
 

dblnkl

Inactive Registered Visitor
#9
Hmmm, since there is only one line here, I can only say that I have to read "between the words" a bit. If the product "has not recieve (sic) marketing approval from the FDA," then I assume either that it must still be in a clinical trial or that the trial was completed and the application for marketing approval filed but denied. In NEITHER case would MDR reporting be appropriate. In fact, this is something to be thankful about: MDR reports are public; NOT having to file public AEs/SAEs during a clinical trial might save us some embarrassment.
 
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#10
Hmmm, since there is only one line here, I can only say that I have to read "between the words" a bit. If the product "has not recieve (sic) marketing approval from the FDA," then I assume either that it must still be in a clinical trial or that the trial was completed and the application for marketing approval filed but denied. In NEITHER case would MDR reporting be appropriate. In fact, this is something to be thankful about: MDR reports are public; NOT having to file public AEs/SAEs during a clinical trial might save us some embarrassment.
Hi, I realize this thread is a bit old but can you reference in which standard or where it is stated when you say "In NEITHER case would MDR reporting be appropriate."? Thanks !
 

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