Rian Wendling Could these product changes significantly effect safety/efficacy?

Emilia Ana Gonzalez Rian Wendling these would just be minor changes that would require only a letter to file with no significant impact on safety- have you heard of the concept of a "catch up" 510k?

Pernelle Kruse Schøndorff In January 2016 an article was published in "Regulatory Focus". Authors: Bailey and Baker-Janis. Try to look that up - very good explanation on catch up 510(k)

Pernelle Kruse Schøndorff https://www.nsf.org/newsroom_pdf/md_raps_rf_catch_up_510K.pdf

Emilia Ana Gonzalez Pernelle Kruse Schøndorff this is where I saw it too! Kind of just wondering if anyone has been through this and if the FDA actually recognizes the concept.

Gary Chuven FDA Memo K97-1. Presently being revised into a guidance document.

Aaron Liang Interesting, this is essentially using a 510k submission as an opportunity to summarize other non-related minor design changes that did not require a regulatory filing (i.e. internal memo to file) as an addendum to the change in the scope of the actual 510k to fill in gaps and provide context between the previous submission and the current submission. I think it is actually pretty smart to do that, it shows transparency from the manufacturer and could avoid unnecessary questions stemming from unfamiliarity or history with the device in question.

Change creep is an issue that has always been an Issue. Each change and the sum of changes should always be compared to the last cleared design when making an assessment. I have submitted catch up 510(k)s and the FDA was appreciative.

Emilia Ana Gonzalez Aaron Liang that is what I was thinking as well. The RAPS article is what sparked my questions on this. I had never heard of the concept and wondered if it was really an industry term or accepted by the FDA. Last night in a RAPS networking event I asked a few people about it. There are people who have done this, but they mentioned it can be risky, it is better to just do a new 510k without calling it a catch up in their opinions. Someone said she has done this as a series of specials- definitely interesting to think about. Gary Chuven I will keep a look out for that- thanks!

Hello everyone. I have successfully obtained two 510K clearances for my OSA appliance. The second was to add indications to it. They are quite clear on their website when a new 510K is required. Here is the link for medical devices: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm134575.htm

I was told initially that a classification review would be needed. I submitted the necessary 150 pages of forms and was then told it was not classifiable but eligible for a De Nova application (to establish a new category). I prepared this and submitted it only to be told I could add a 2nd 510K to the same device. One for medical and one for dental. So, back to the drawing board, I prepared a new 510K for the device which was accepted. This cost under 10K to do but in terms of time, took from January to July! I have to say though that they were very helpful and very courteous at all times,
Ken

Aaron Liang I agree, it can draw their attention to matters that otherwise would have been under the radar. In my experience I have never done a catch up 510(k) as a standalone submission, but as a courtesy to the reviewer for the submission in question, summarized design creep between the prior submission (usually used as a predicate) to bring them up to speed and avoid confusion. I guess there is an art in doing it smoothly such that it doesn't create more problems.

Please refer Medical Device Change(s), Analysis and 510(k) Impact
Link: http://www.complianceonline.com/medical-device-changes-and-the-510-k-webinar-training-701742-prdw?channel=sumukh

Martin Mitchell I spoke to the FDA about this recently. When I referred them to the RAPS article which explained the "catch up 510(k) submissions" The FDA stated that they had concerns about what the article was suggesting to the readers and stated that we should not follow the process which RAPS were advocating.

The FDA reconfirmed that the only two process they required us to do was that if we had non-significant changes you document them internally and inf you have significant changes you submit a 510(k) for approval before they can be implemented.

The FDA did however, suggest that if we wanted to inform the FDA of non-significant changes we could do so through an "add-to-file" which would take the form of a 510(k) supplement. However, they restated that the FDA have no requirement for this process and that there is risk that the FDA investigator deems the change to be significant and requests a 510(k) to be submitted.

Martin Mitchell It seems as if change creep has occurred and you wish to lower the risk of a particular 510(k), there is no simple way to go about it.

You can either have confidence that the changes were non-significant. The current product can remain on the market. However, during an audit the FDA may determine that the changes were significant and request a 510(k) to be submitted.

If you decide you wish to submit a 510(k) to inform the FDA of all the non-significant changes which have occurred you are essentially stating to the FDA that the current device has actually undergone a significant change and therefore the current device shouldn't be sold on the market until the FDA have reviewed all changes.

If you decide to submit an add-to-file to inform the FDA of all the non-significant changes this could lead to a situation where the FDA think a significant change has occurred and therefore your current device shouldn't be sold on the market.

Emilia Ana Gonzalez Martin Mitchell that is all good to know, the article is what sparked my curiosity on this and it's good to hear input from the FDA on the article itself

Rob Packard The FDA published a draft guidance document on device changes August 8, 2016: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm514771.pdf. Unfortunately, that document does a great job of addressing a single change and how to document that change, but it doesn't address the question of multiple sequential changes over time. Ultimately, each time you make a change you have to look at the significant with regard to safety and efficacy since the last cleared 510(k). The more changes that are made the greater the chance that a new 510(k) is needed. You might also consider submitting a 510(k) as a catch-up even when it's not required, in order to to reduce the gap between the current version and the last 510(k). This ensures that you 510(k) documentation remains current every year.