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TIFUpate: allowing my coworker to set me up

TIFU by instructing all of my company's upper management to look at a list of vibrators during a meeting.

I'm a biomedical engineer, I make cool medical devices. A really, really important part of developing medical devices is to understand the necessary regulations to ensure that the FDA doesn't drop the hammer on you.

Brief FDA background: I'm going to grossly oversimplify this for brevity's sake, but every medical device category has a 3 letter product code that determines how its reviewed and the controls that are put on it. If there isn't an existing code, then they'll make a new one for it. For some low-to-moderate risk devices, you can point to an existing device on the market and use it as a benchmark for safety. "This device is on the market and is safe. We have a bunch of data to show we're substantially equivalent. Please don't make us do years of human studies to demonstrate that our new tongue depressor design won't kill anyone." The FDA has a super handy database where you can type in the product code and it'll give you a list of all devices under that produce code that were cleared using this approach. It's here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Unfortunately, when you search a product code, it's done dynamically at the same URL. So if you want to share search results, you need to instruct others to repeat the search. I was presenting our regulatory strategy to all of upper management for a new medical device. I told them to bring up that site.

What I intended to say was this: "We plan to pursue regulatory clearance for our new system using one of the previously cleared devices under product code KQX as a predicate device. Go ahead and search it to see some examples."

That should have popped up devices under product KQX: "Goniometer, Ac-Powered"

Instead, what I actually said was this: "We plan to pursue regulatory clearance for our new system using one of the previously cleared devices under product code KXQ as a predicate device. Go ahead and search it to see some examples."

I waited about 15 seconds for anyone to say "yeah, I see what you mean," but it was dead silent. Everyone had very confused looks on their faces. For I had misspoke and unintentionally instructed them to look at all previously cleared devices under product code KXQ: "Vibrator For Therapeutic Use, Genital".

Because I'm far better versed in FDA regulations than upper management, when the first person broke the silence and asked "Uh, I don't think this will work," I doubled down and responded with "look, some of them may not seem like a perfect match, but the 510(k) definition of substantial equivalence is pretty wide. I've seen a tongue-controlled communication device (similar to the system a quadriplegic would use to control their wheelchair) get cleared using an ergonomic keyboard as a predicate device. I have little doubt."

There was a long silence before another person chimed in with "you feel that you can argue to the FDA that our [REDACTED PRODUCT NAME] is substantially equivalent to the 'Viberect Penile Vibratory Stimulation Device?'"

It was only then that I realized that I'd fucked up. After a quick clarification, I gave them the proper product code and we moved on.

TL;DR - Switching two letters in our in-development medical device's product code gives the product code for genital vibrators. Guess which one I told upper management to review.

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