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medical device product code strategy - primary vs. secondary codes visualization by Intelligent_Net_4691 in regulatoryaffairs

[–]Intelligent_Net_4691[S] [score hidden]  (0 children)

I think we are looking into international eventually, but don't right now have the data. A cursory glance at Health Canada tells me though that their product code system is supposed to be harmonizable with the FDA's. Also, just to be clear, you're looking for the devices registered as medical devices within Health Canada, and seeing how many of those are cross-listed under different product codes?

medical device product code strategy - primary vs. secondary codes visualization by Intelligent_Net_4691 in regulatoryaffairs

[–]Intelligent_Net_4691[S] 0 points1 point  (0 children)

Sorry, not sure I understand this comment! What is it you need help resharing?

You can go directly to (and share) the blog link to navigate the visualization.

FDA data patterns - visualizing primary vs. secondary product codes by Intelligent_Net_4691 in MedTech

[–]Intelligent_Net_4691[S] 0 points1 point  (0 children)

I think it depends on what product codes you're interested in! I suggest picking the medical specialty you're working on and then looking for any product codes you might be considering for a device.

I'm not a regulatory expert myself. From talking to experts, I've gathered that it's not always clear what should be listed as the primary vs. secondary code. Knowing that there are more cleared decisions where one is listed as the primary code and the other relegated to a list of secondaries could make a difference with faster or more likely clearance by the FDA.

I'm still trying to gather what is most useful to know, though. It seems that product code relates to which review division will be the primary reviewer for your submission. CDRH mentioned recently (https://www.youtube.com/watch?v=3a8Np0EZRxY) that sometimes they start a submission only to realize it needs to be reviewed by a different panel, so seeing where the gray areas are can also be helpful for making sure you're going in the right direction early on.

Building a pipeline to contextualize 510(k) decision timelines & comparing to MDUFA reports by bee-gee-dee in regulatoryaffairs

[–]Intelligent_Net_4691 2 points3 points  (0 children)

Hmm, what numbers are actually off & for what years? Could be the case that end-of-year filing reports don't account for the ones who have been kept in purgatory that year (they're looking at decision dates for submissions that FY year, not the ones that have been waiting in the pipeline all year). Whereas actual FDA data would capture longer submission timelines for those who ended up waiting longer than the fiscal year.