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Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
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Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
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Some Related Topic Tags
510(k), add to file, convenience kits (medical device), fda (food and drug administration), letter to file (fda term), medical devices
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  Post Number #17  
Old 10th October 2010, 06:51 AM
Ronen E

 
 
Total Posts: 3,736
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Quote:
In Reply to Parent Post by rakma View Post

Hi,

I just inquired with DSMICA regarding a change we are making to our 510(k) cleared device. They recommended referring to the FDA flowchart in "Deciding when to submit.." (which I already had) and sending an Add to File to the referenced 510(k) to FDA! This was the first time I heard of this terminology. Then i saw your forum and joined it. I am now wondering, should I document the change internally or send this add to file to FDA. The change is in the packaging of the device components: originally the device components that were sterile were packaged in individual pouches and then the pouches were packaged in a box labeled a kit. Now we want to put those devices ina single tray, sterilize the tray and label it as the kit. Note the devices were provided sterile earlier but now the way they are packaged in different. We will be reperforming the sterilization validation for the new tray and package. But i wanted to confirm if this is a change that would require a special 510(k) or just internal documentation.

Any suggestions on how this change should me handled?

Thanks,
Hi,

In my opinion this would definitely require a special 510(k), as this is a substantial change in the technological characteristics of the product, and could definitely affect safety (if not done properly). This is also in line with the excellent explanation above from bclichten, according to which the older "add to file" has later become today's special 510(k). Perhaps you spoke to someone from the old school...

Cheers,
Ronen.

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  Post Number #18  
Old 26th April 2011, 12:34 PM
Laughing Pierre

 
 
Total Posts: 25
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Hi,

Coming to this thread late, BUT...

I've just had a request from FDA to "send an add-to-file to the cleared 510(k)" and have no idea how to do that. The request has come after we have told FDA that we have worked through all of the guidance and have determined that a new 510(k) of any variety) is not required.

The "new" device is a version of a cleared device which has been modified to significantly reduce the risks associated with it. We want to get the modified device listed with the original device so that there are no problems with it clearng customs.

Our communication from FDA seems vaery similar to that experienced by rakma. In the intervening period has anybody out there discoverred how to submit an add-to-file and what format it should take?
  Post Number #19  
Old 26th April 2011, 10:26 PM
Ronen E

 
 
Total Posts: 3,736
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Quote:
In Reply to Parent Post by Laughing Pierre View Post

The "new" device is a version of a cleared device which has been modified to significantly reduce the risks associated with it. We want to get the modified device listed with the original device so that there are no problems with it clearng customs.
Hi,

In my opinion, it all comes down to the nature of change. From the little info provided I gather that the intended use was not changed (or was it?), and so the special 510(k) decisive question is "was there a substantial change in the technological characteristics?". You state that your goal was to significantly reduce the risks associated with the device, but how was it done? If the technological change was substantial, then a special 510(k) is required. It doesn't matter if the change was an improvement or not; either way you have to clear it. Regarding the ambiguity of the "Add to file" terminology, I would have presented a direct question to the FDA if I was in a similar situation.

I'm not sure how all this relates to clearing customs, but I'm no USA customs expert anyway...

Cheers,
Ronen.
  Post Number #20  
Old 1st August 2013, 03:48 PM
drewsky1

 
 
Total Posts: 122
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Our company would like to create/revise our SOP for Deciding when to submit 510k or not when an existing product may need a design change. WE call it a Regulatory Assessment document which is made to determine this and we keep on file. It is not a letter file but a regulatory assessment decision. Does anyone out there have an SOP like this in there company? What type of questions should be asked to the R&D, Mfr Depts that will be initiating the change?

Thanks
  Post Number #21  
Old 1st August 2013, 03:55 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Quote:
In Reply to Parent Post by drewsky1 View Post

What type of questions should be asked to the R&D, Mfr Depts that will be initiating the change?
You should be starting from the decision-question-list in the FDA deciding-whether-to-submit guidance.
  Post Number #22  
Old 1st August 2013, 06:48 PM
Ronen E

 
 
Total Posts: 3,736
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Please note that the FDA is currently in the process of reviewing the current practice and guidance. Probably a new guidance will be published some time in the foreseeable future.

More details: http://www.fda.gov/MedicalDevices/Ne.../ucm347888.htm
  Post Number #23  
Old 1st August 2013, 09:43 PM
drewsky1

 
 
Total Posts: 122
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

yes, that would be best. Just wanted to get input on other SOP's that other's may be using.

Thanks
  Post Number #24  
Old 30th September 2013, 05:47 AM
cff920

 
 
Total Posts: 9
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Lately, it appears that FDA is making efforts (or struggling with) to clarify two grey areas:
(1) Malfunction and the criteria of its reportability;
(2) Threshold that a design change to trigger 510(k) submission

Both areas are sensitive, and a firm could easily be given 483 and Warning Letter, if any violation is detected in FDA inspection.

But, despite the suffering that the industry had, FDA has the most comprehensive and informative database of device adverse events among all regulators. I personally respect FDA's achievements in this, although I dislike FDA.
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