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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"
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
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 #33  
Old 4th August 2017, 07:14 PM
jinglot

 
 
Total Posts: 13
Please Help! Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Hi,

I realize this thread is old but hoping someone can help. Is there anyone who can help distinguish between minor changes (i.e. ECO justification is enough) and Letter to File changes? We have a good handle on what should be a submission but I am concerned that we are doing too many letters to file when the changes are truly minor and should not warrant that level of scrutiny. However, I don't have a good way of defining that. Any ideas are appreciated!

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  Post Number #34  
Old 1st March 2018, 06:29 AM
Highground

 
 
Total Posts: 32
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

I would add all the minor changes when you update a 510K submission with a major change.
  Post Number #35  
Old 5th March 2018, 05:25 AM
MDSilva

 
 
Total Posts: 1
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Hi everyone,
I know some of these posts are older, but with regards to Letter to File format, the current version of the Guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” has in its page 64 and 65 examples of how the letter to file could look like.
Thank You to MDSilva for your informative Post and/or Attachment!
  Post Number #36  
Old 5th March 2018, 09:10 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,205
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Thanks MDSilva and welcome to the Cove
  Post Number #37  
Old 23rd March 2018, 11:45 AM
JasonDanner13

 
 
Total Posts: 4
Please Help! Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

I wasn't sure how to make another thread so I added it in here. I am part of a startup company who got a 510K as a contract manufacturer. We sent a design to our predecessor company, they built the medical device, and sent it back to us for packaging and sterilization.

Now, we have deemed our manufacturing process superior to our predecessor and want to manufacture the piece ourselves. The process changes we instituted do not change the product in terms of looks or function. It may make the device safer in a worst case scenario, but I wouldn't say our device is superior in safety either. Rather, we just optimized the process to create better flow, shorten the manufacturing process, and minimize the amount of raw materials we use in the process.

We do have information that could support our product being safer than the predecessor, but not significantly safer.

My question is: Do we need to get another 510K since we did alter the manufacturing process? I've read some of the FDA's wording on this and they tend to use the adjective "significant" changes to the manufacturing process. But, I don't know how to categorize what is significant and what is not. And because of this confusion, I am not sure if we need to apply for another 510K or not.

If anyone could help I'd appreciate the input!
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