Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"

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tallu

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

So, in the letter you only refer to "chapters of the book"?
 
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jinglot

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!
 

Highground

Involved In Discussions
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.
 

MDSilva

Registered
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.
 

Ajit Basrur

Leader
Admin
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Thanks MDSilva and welcome to the Cove :bigwave:
 
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JasonDanner13

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!
 

robert.beck

Involved In Discussions
all of the above posts on topic are old. just want to let anyone who's interested know that today in late 2018, the Letter-to-File (LTF) method is used often to justify why product changes do not require a new 510(k). it's done on a risk basis, and following the flow chart. the best LTF is an index to supporting documentation. this varies by product but can include purchasing controls, process verifications, software verifications, and anything that supports that the changed product is still safe, effective, and substantially equivalent to the original product. I am working on a template for this type of document, and will probably post it on my website after it's been used a couple of times by real companies. here are two recent, relevant guidance documents:
Deciding When to Submit a 510(k) for a Change to an Existing Device, 8/2017
Deciding When to Submit a 510(k) for a Software Change to an Existing Device, 10/2017

see also this article, which uses the term "Letter to File" in its title:
https://www.insidemedicaldevices.co...or-new-510k-cdrh-finalizes-two-key-guidances/
 

robert.beck

Involved In Discussions
Hi,

I have come across the term "Letter to File" and "Add to File" on several occasion, when reading about "change of existing medical devices and 510(k)."

The FDA site gives no explanation of the term.

I suspect is it an unofficial term for a Special 510(k) though I´m not sure...

Does anyone use the term or know if it has an exact meaning?


regards t.
I have used the letter to file method for small changes to make sure the regulatory files are complete. it is a defensible position when you don't want to file a completely new 510(k). there is a guidance document for this, which has been revised and superseded. try searching for "when to file a new 510(k)." The guidance document is titled "Deciding When to Submit a 510(k) for a Change to an Existing Device," it has a lot of information and good flow charts. "Letter to File" is listed as an option on pages 64 and 66 of this guidance document. url: Deciding When to Submit a 510(k) for a Change to an Existing Device
 
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