Aaryak Joshi Hello Sandra, assuming the errors from my interpretation biases and other unknown variables of the exact situation and changes, following are my thoughts:

I am dividing you question in two parts:
Part One:
"documentation" - the definition given is correct, it to document everything, creating various records for future references, that is the general quality process framework...so for all the processes, analysis, results, etc. what this guidance suggests is that you create records for all the changes, their origin, reasons, engg aspects, tests designs, tests results, analysis, etc..however please keep in mind that in the flow chart, it does not suggest that after all the analysis you just keep the information in records for future reference...it simply states that you should keep records of all relevant activities..

Part Two:
When you should submit anything to FDA:
This is where you will have to review the change carefully as per the guidance,..... to start with what aspects is the change affecting, and then run the comparison, with the previous device to understand whether such a change needs to be reported to FDA, in the form of amendment or new 510k, etc..

Case 1: Let us say if you determine, that you need to submit a new 510k, then the documentation that you created while analyzing the change, information from that document will be helpful for compiling the new 510k,

Case 2: Let us say you determined, that you need to submit an Amendment, then again the documentation records will be helpful, to compile the amendment.

Case 3: Let us say you determine you do not need to report anything, then that documentation, will be helpful for future references and auditing purposes.

However do keep in mind, that information required to compile either the amendment or the new 510k will not be limited to the information recorded in the documentation specific to the change, information from other new and previous sources may also be required, depending on the type of submission.


The third part - "adding models to one 510k" is in my opinion... more of a strategic process, requires a case to case basis analysis, I believe fellow group members will be able to answer that better.

Hope it helps.

marc henn Sandra:
Of course this depends upon the type of changes you are making, however, If you are looking at the flow charts in the referenced document, Documentation usually indicates a letter to file. In the letter to file, you document your reasoning why you did not need to create a 510(k) submission. The letter to file is your internal document or "proof:" you have reviewed the changes and based on guidance do not need to create a 510(k) submission, the letter to file is not sent to FDA, however, could become a topic of discussion if you are audited. Of course you have to also continue your normal documentation required for medical devices per Design controls, GMP's etc. If you follow the flow charts, again depending upon the changes you are making, you can also end up needing a submission. Either a traditional 510(k) or special 510(k) etc. which of course is sent to the FDA for their review, questioning and eventual clearance provided it is warranted.

Dan O'Leary When you analyze the change, don’t use just the flow charts. They have questions associated with the decisions, so be sure to write specific answers to the questions. Map the path through the decision making process so another person can easily see the path, read your responses, and explain it to an FDA Investigator.

This analysis is part of a design change in 820.30(i). Put the results of your evaluation in the DHF associated with the design change.

When you conduct a design change, there are issues you must consider that are not in 820.30(i).
* change analysis is one of the considerations, but others include determining if the change creates a new version or model and requires a DI under the UDI rule, the reason for the change and the potential to report it to FDA as a Correction/Removal, determine if the change affects a hazard or hazardous situation and requires an update to the Risk Management File.

Sandra. given the importance and potential for expensive corrective actions & lost time/sales with the FDA, I would recommend getting a consultant who is an expert with a long history in FDA 510 (k) submissions to do some consulting & training.

It is always tempting to "do it ourselves," but when there are potentially significant & costly unknowns, it is time to get top notch advice to avoid downtime.

Diane Rutherford Sandra,

As Dan said, do not simply follow the flowcharts. The flowcharts are a handy reference, but as clearly stated in the guidance document, are NOT a stand-alone tool.

I would strongly avoid documenting your review using a Letter to File. Your review should be a controlled document (i.e. form) that is part of your quality system. This Regulatory Review should be part of the design process during development of new devices and modifications to existing devices.

Again per the guidance, you should review the current modification to your existing cleared device, AND all changes made since the device was cleared. Each change is cumulative for this review process.

If you find you should submit a 510(k), depending on the impact of the modification, you would either submit a Traditional or Special 510(k). The only time you would be notifying FDA of the modification is through the submission of a 510(k).

"Documentation" refers to all of the documents required by design control as well as the record of your regulatory review [does this modification trigger the need for a new 510(k)?] and any other quality system documentation. A "Letter to File" is not sufficient documentation - you need the entire body of documentation, again as Dan stated, in accordance with 820.30(i).

As far as adding additional models under the single 510(k) number, this really depends on what was cleared in your original 510(k). A 510(k) can be extremely narrow and focused, or it can be written in a manner to allow for the expansion of your product line to be covered by that original clearance, more of a product family clearance than a single model clearance.

And always, if your additional models are not derived from the original device (traceable as modifications through the associated DHF), then these would be new devices, not just new models and would require 510(k) submission(s).

Be very careful about listing devices under 510(k) numbers that are not applicable to the device. I know it happens, but if the listings are not correct, your devices are will be adulterated or misbranded.

The text below is from the FDA website here: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm073752.htm

"only devices that do not differ significantly from the specifications described in a 510(k) (including conformity with a standard) are the subject of a substantial equivalence determination for the 510(k) and can be legally marketed based on that clearance. Devices that do not have a required 510(k) clearance are adulterated and misbranded, and marketing an adulterated or misbranded device is a prohibited act. "

marc henn Sandra, All:
Just to be clear, When I stated the term "letter to file" this is not just a simple 2 paragraph letter. It contains all of the considerations already mentioned inclusivie of design control documentiaton, analysis of the sum of all changes since product clearance, regulatory analysis etc.. It is just that this is documented in internal files (design files etc.) I also agree with others, one cannot just follow the flow charts when considering changes, considerations that have to be made for changes to a device when determining if a submission is needed are not would take a novel to explain, if not expereinced in this area, as somebody already suggested , perhaps a consultant with experience is the best path to pursue for advice for your particular situation.

Sandra Chen Is the "letter to file" included in the Engineering Change Requirement(ECR)? And need the reports to support the changes? Such as the test reports under IEC/EMC rules or ISO regulation.
Consultant is really important to understand the rules of 510(k) and communicate with FDA.
I should evaluate the changes with my manager again and see what should we do after the modification.
Thank you all for the suggestions.
I think I understand a little more things about the 510(k) after this.
I do appreciate!

Diane Rutherford Sandra,
"Letter to File" (LTF) is a term used by many companies to mean many different things. As Marc commented, at his company, a LTF is a controlled document that is part of the company quality system with a procedure outlining what is required in the LTF. In my experience, Marc's company is in the minority. Again, in my experience, a LTF is typically a short memo and is many times written to address a deficiency rather than to document a required element. I would be cautious in adopting the LTF terminology within your quality system unless it is clearly defined and controlled. When used, the LTF would be addressed to a location, for example the design history file (DHF) of a specific device, and would be filed in that location or with the record the LTF is addressing. Feel free to message me with additional questions.

Richard Reilly If the changes are minimal, the FDA may accept an "Add On File" to the current 510k which details the changes, the design, validation and new labeling of the modified version. All modified labeling would be sent in with the file. The add to file document must demonstrate:

· The changes to the product do not change the intended use or the indications for use of the product.
· The changes do not affect the safety or effectiveness of the product.
· The labeling will not add or delete any contraindication.
· The change does not alter the operating principle or control mechanism.
· There are no environmental changes.
· There are no changes in performance specifications.
· There will be no change in ergonomics.

This would be submitted to the FDA for review as you would submit other submissions. It may be best to call prior to submitting and receive recommendations based on your modification.