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

temujin

Inactive Registered Visitor
#1
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.
 

Ajit Basrur

Administrator
Staff member
Administrator
#2
Re: 510(k) and "Letter to File"

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.
Significant changes to the device’s design, manufacturing processes, product claims, or indications may require additional activities.

Minor changes may only require a “letter to file”.

Major changes may require updates to the labeling, review by the FDA, or even a new device listing.
 
#4
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

I too am investigating this "Letter to File" terminology. Here's my take: The FDA Guidance Doc flow charts all end at one of two choices: "New 510(k)" OR "Documentation".

My take is that "Documentation" should be interpreted to be whatever existing documentation one maintains to support and justify changes to an existing device, e.g. the Engineering Change Order and its supporting documentation. I believe the expectation is NOT for an additional justification, e.g. a "Letter to File". If this were the case, then one would be asking the question "what's the difference between "Documentation" and a "Letter to File", and what is the threshhold for moving from one to the other?" It has not been my experience that this is the Agencies intent.

The "510(k)" path, on the other hand would likely be a "Special" 510(k) assuming the change being proposed is to your legally marketed device.

So if anyone else has any different take on the Genesis, intent or meaning of the "Letter to File" term, I'd love to know about it!
 

temujin

Inactive Registered Visitor
#5
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Thanks for the input,

Even though time has passed since I started this thread, I still did not find any answer.

I interpreted it as "Documentation" = "Letter to File" , as something that just needs to be documented, and not reported to the FDA.

Could it be that the term "Letter to File" comes from a time before the new 510(k) paradigm ?

regards
t.
 
B

bclichten

Guest
#6
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

I started working in regulatory a few years before the FDA changed to the new 510k paradigm and the format of Traditional, Special and Abbreviated 510k.

From my experience, "Add-To-File" was a previous version of "Special 510k". Before when you had a major change to a current product 510k, you would submit the changes to the FDA under "Add-To-File" which meant "Add To the current 510k File". Now you submit the changes under "Special 510k".

The definition of "Letter-To-File" has never changed. This is a simple 1-3 page brief summary on why you think you don't need a 510k submission. Attached to this is a copy of the R&D/Engineering notes on the change. The memo briefly explains the change, whether biocompatibility testing was/was not done and why per ISO 10993-1, how the change does not effect safety and efficacy, and a summary of data to support your explainations. I always attach a copy of the FDA flow charts from the guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Device" with my notes on all relevant parts of the flow chart that apply.

Now if the change is minor enough, you don't even do a "Letter-To-File". Just record the design change data in the device design records. The hardest part sometimes is defining consistently in a company what does and does not require a "Letter-To-File". It depends a lot on the risk and classification of a product. My rule of thumb is if I have to use the FDA flow chart, at a minimum I write a "Letter-To-File".

So far every company I have worked for has roughly followed this pattern. I was originally trained on how to do 510k's from a manager that was submitting docs to the FDA since the early 1980's when a 510k was just 3-4 pages long. Man has that changed!!

Does anyone else have a different experience? :)
 

temujin

Inactive Registered Visitor
#7
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Hi,

Welcome to the Forum and thanks a lot. It looks like this was exactly what I was looking for....


regards
t.
 
R

rakma

Guest
#8
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

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

The references of "letter to file" or "add to file" pertain strictly to internal documentation. There is no regulatory requirement to provide this type of documentation directly to FDA. When it comes to changes to a medical device, here are the regulatory options:

1. Documented per QSR design & change control requirements (no "letter to file")
2-Same as #1, but including additional documentation, e.g. the "letter to file" that, in essence, explains why no 510(k) is required.
3-Same as #1 + Special 510(k)
4-Same as #1 + Abbreviated 510(k)
5-Same as #1 + Traditional 510(k)
 

MIREGMGR

Inactive Registered Visitor
#10
Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

I haven't previously heard of any middle ground between a Memo-To-File into your own local product documentation, and a Special 510(k). Obviously the Special 510(k) when-required guidance is relevant, as also may be "Convenience Kits Interim Regulatory Guidance", which I believe is the most recent FDA guidance on kit regulation.
 
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