Source: https://www.medtechintelligence.com/column/significant-design-change-requires-fda-notification/?shared=email&msg=fail
Timestamp: 2020-03-31 22:40:13
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Matched Legal Cases: ['art 807', 'art 814', 'art 890', 'art 820', 'art 807', 'art 807', 'art 807']

Column | Significant Design Change Requires FDA Notification | MedTech Intelligence
Dr. D frequently sees device establishments default to the infamous and often problematic “Letter-to-File” when documenting their design changes versus taking the time and actually notifying FDA, as required in accordance with Part 807 requirements, or the filing of a PMA supplement in accordance with Part 814. Regardless, the FDA does have the authority to pursue regulatory action, including the issuance of a warning letter for entering a misbranded product into interstate commerce and the detention of products being shipped into the United States. For device establishments that fail to recognize when FDA notification of a design change is required, the Chief Jailable Officer (CJO) will be forced to offer a continuous stream of abject (look-it-up) apologies to the FDA. Enjoy!
Now granted, benign design changes that have zero impact on product safety and efficacy, and do not influence or modify the intended use of the device are probably candidates worthy of the letter-to-file approach. However, when additional operational modes are added for a previously cleared Class II device (K121719 – Part 890.5850) and the FDA is not notified of the changes, bad things will happen to the establishment that is entering the modified device into interstate commerce. Can you say warning letter? Can you say product detention? Can you say misbranded product? Can you say adulterated product? Seriously, the offending device establishment referenced in this week’s Devine Guidance (DG) received a warning letter in December 2015 for their failure to notify the FDA about significant design changes made to multiple products. In fact, the FDA also took issue with this establishment’s quality management system (QMS). Combine adulterated product with some quality system regulation compliance issues associated with the QMS, and the perfect storm begins to unload on this offending establishment. The doctor hopes the CJO has a really big umbrella.
“During our inspection of your facility, your firm specifically identified K121719 as the applicable 510(k) clearance for your Elite Massagers.
Specifically, you have modified the Elite Massager Multi-Pro, cleared under K121719, by increasing the “massage modes” to eight. The device cleared under K121719 only has “six operation modes.” The change in the number of operational modes constitutes a major change or modification to the device’s intended use, for which you lack clearance and approval.”
21 CFR, Part 820.30 – Design Controls
“(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.”
21 CFR, Part 807.81 – When a Premarket Notification Submission is Required
“(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:
Let Dr. D begin by emphatically stating, “the doctor cannot tell the readers what constitutes a significant design change.” That decision must be placed squarely on the shoulders of the R&D, quality, and regulatory personnel in each of your establishments. However, please keep in mind that these decisions are premised on a whole bunch of common sense. For example, if the indications for intended use changes or is expanded, then Part 807 becomes quite relevant. For example, if a urinary drainage catheter, designed for the adult population, has an expanded indication for pediatric use, you just might want to consider filing a new 510(k) for the expanded indication for use. However, if a circuit is redesigned due to the lack of continued availability of electronic components for an RF generator and the change has no impact on the performance of the finished device, then a letter-to-file placed in the Design History File (DHF) is probably going to be appropriate.
Regardless, the FDA expects device establishments to pursue specific steps when a design change occurs. Elements the agency expects to see for all design changes include:
All design changes must be clearly identified and documented, regardless of how benign a design change appears to be
Depending upon the design change, the change shall be appropriately validated and/or verified (test, test, and test again, if necessary)
Prior to implementation, all design changes shall be adequately reviewed and approved
Depending on the design change, FDA review and approval may be warranted either by 510(k) or PMA
As Dr. D has mentioned on many occasions, adherence with regulatory and statutory requirements mandated by FDA does not take a rocket scientist. However, it really does take some common sense, and frankly common sense is a trait that is missing for some CJOs.
For this week’s guidance, Dr. D will leave the readers with just one takeaway. If a design change is forthcoming to one of your establishment’s finished medical devices, please apply a little bit of common sense when it comes to notifying FDA. If the design change impacts form, fit, or function and/or the intended use of the finished device is changing or being expanded, then rest-assured, the agency is going to want to know about it. Please do not be that establishment that receives a warning letter because of design changes not being cleared or approved by FDA. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.
Code of Federal Regulation. (April 2015). Title 21 Part 807: Establishment registration and device listing for manufacturers and initial importers of devices. Washington, D.C.: U.S. Government Printing Office.
FDA. (December 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Elite Massagers, LLC. Accessed February 8, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm477579.htm
Chris Devine design changes design controls FDA warning letters
Dan O'Leary February 11, 2016 at 1:22 pm
It would be interesting to know if the firm followed the current guidance and, if so, what they concluded.
It would be equally interesting to see the results of any person, well versed in the guidance document, on the decision to submit.
Dr. D February 14, 2016 at 4:02 pm
Dan, good afternoon and thank you for reading DG. My assumption is that this establishment failed to follow any of the agency’s guidance docs; henceforth, the warning letter. Be Well,
Jacques Ginestet February 27, 2016 at 12:27 pm
Dr. D., could you help me with the exact definition of “letter to file”. It is a term often used (misused?) in the med device industry, but I have failed to find an authoritative definition anywhere. Searching the FDA’s web site, and all its guidance documents, nothing came up. All the FDA says when the decision is made not to file a 510(k) after a change is to “document” (the changes, their V&V, etc. as well as how this decision -not to file- was arrived at). It seems implied, per the manufacturer’s Change Control SOP. This notion that there is a “special” form of documentation called “letter to file” does not seem to be have any basis… Are you aware of such an authoritative definition for “letter to file”, and of course what its content, format, etc. should be?
Dr. D March 22, 2016 at 10:02 am
Jacques, good morning and sorry for the delay in my response. You are correct in that the LTF does not exist in the FDA’s world. Device establishments use it as a tool to document their rationale when decisions specific to meeting a regulatory requirement are made. For example, if a decision is made to change the color of a catheter shaft from red to blue, the LTF documents the rationale, including any testing performed on the colorant used. The change, in and of itself, may not be worthy of a special or abbreviated 510(k); however, why risk alienating the agency when the correct path is to document the rationale for making the change. Thanks for Reading, Dr. D
robert nami August 26, 2016 at 7:37 pm
This is a great discussion thread. Can someone post a template of a form that is perhaps used as “cover page” if you will of the documentation package that is generally used to detail rationale for change as well as the ensuing V&V efforts?