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The following content is a copy of Q&A between Rob Packard and a client asking about the need for a change control procedure when making medical device modifications. If you would like to purchase Medical Device Academy's change control procedure (SYS-006) that includes the letter to file form (TMP-029), please visit the link provided below: ➤ https://medicaldeviceacademy.com/chan... Q1 - If understand correctly, after evaluating a device modification using the “letter to file" form you provided, if the device modification does not require a 510(k) we can perform a change control and market the new version of our product, is it right? A1 - Yes, that is correct. You also need to perform change control, and the purpose of the "letter to file" is to document your decision regarding whether a new 510(k) is required. If a new 510(k) is required, we also recommend creating a new Design History File (DHF) for the device modification. Q2 - What are the consequences of FDA disagreement with our conclusion in the "letter to file"? Stop Marketing? Withdrawal from the market? Warning letter? A2- All of the above are possible. Generally, the process begins with the FDA noticing the new claims on your website or a competitor complaining to the FDA. In either case, the FDA response is a letter that begins with "It has come to our attention..." You generally have three possible outcomes: 1) submit a 510(k) and continue to market your product in the interim, 2) submit a 510(k), but discontinue marketing and distribution in the interim, and 3) submit a 510(k) and withdrawal of the product. A Warning Letter only would occur if you neglect to respond to the FDA letter appropriately and fail to submit a 510(k) in the agreed time period. The letter will ask you to contact the FDA for a conference call. In your call with the FDA, one of the above outcomes will be agreed upon, or the FDA will ask for information so they can make the determination of which path is most appropriate. Their decision is based on adverse events, complaints, and risks. If there is no potential for harm then they do not require a withdrawal. In general, the FDA expects you to submit a 510(k) in 6-9 months because your validation should already be done either way. Q3 - We sometimes have several device modifications integrated into the same approval of design changes. Should we fill in one "letter to file" for all the changes combined? Or should we have to fill in one “letter to file” for each device modification? A3 - The "letter to file" should incorporate all changes in a single release. Therefore, if you make all the changes at one time, then just one form is needed. The more changes you make, the greater the cumulative risk and the higher likelihood that you should be submitting a 510(k). This is also true for cumulative changes due to multiple letters to file over time. Q4 - For CE Marked products, we modify the applicable documents in our DHF for device modifications. I do not understand how to modify just the Device Master Record (DMR) for device modifications. Can you please explain how to do this? A4 - The DHF should be for a specific design project and a specific design plan with a start and a finish. At the beginning of the project, you would fill in the letter to file. If it looks like you might need a new 510(k), you should create a new DHF. If the letter to file looks like you don't need a 510(k), then you do not need a new DHF. You only need to update your DMR. The DMR should be an Index that lists the current version of all files. There is no need for historical documents in the DMR. Instead, I recommend having a revision history for your DMR Index. The revision history will reference each design change approval and the letter to file will be included for each design change approval. I also recommend using the DMR as your Technical File (TF) Index for CE Marking. There is no required format for a DMR, so you might as well use the same format required for your TF and maintain one index instead of two. Not every company does things as I have described. Some companies try to update a DHF, but this makes it much harder for auditors and inspectors to review your DHF because the DHF will now be comprised of multiple design plans. If you are interested in purchasing our Technical File (TF)/Device Master Record (DMR) Index, that is available as part of SYS-025: ➤ https://medicaldeviceacademy.com/ce-m... If you would like to schedule a meeting with Rob, please use the following calendly link: ➤ https://calendly.com/13485cert/30min Timestamps (need to add some more stamps): 0:00 Intro to Change Control / LTF 1:39 Q1 - Is change control approval enough 5:12 Q2 - What if the FDA disagrees? 8:51 Question from the audience 12:07 Q3 - Do we need multiple LTF or just one? 14:24 Q4 - How do we update DMR?