Dear Umang
Great suggestion! I did the following based on your instruction:
1. download the Product Code foiclass.zip from the link
2. use the key word "insomnia"
3. find 2 product code "PLU" and "QJQ"
4. Go to FDA 510k, PMA, De Novo databases to search by the two product code.
There is no device cleared under QJQ and only 1 device un PLU, DEN140032.
The whole process takes me about 2-5min ish to follow your link, download the file, then use "key word" search.
However, if I use my search engine and search by devices' indications to use, using the same keyword "insomnia", there are 8 devices that has mentioned "insomnia" :
6 under JXK: K024377, K060158, K062284, K070412, K090052, K182311
1 under PLU: DEN140032
1 under LQD: K141865
So my follow-up questions, if my goal is to find a device treating certain disease or have certain features, e.g. stainless steel vs. titanium alloy; how can I make the search that exhaust all possible devices? When people search for a device to find out if this device will be their ideal predicates, they normally start off with product code? How satisfying to use product code to search for devices vs. alternatives if enabled by technology? How often do people search FDA databases and how much time do people normally spend on FDA databases?
Thanks,
Michelle
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Michelle Wu
Palo Alto CA
United States
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Original Message:
Sent: 28-Sep-2020 09:45
From: Umang Shah
Subject: How do you search FDA medical device database?
Hi Michelle,
If you download the file from "Download Product Code Classification Files" run a search on key word such as insomnia you will be able to identify the product code for further details. In any case would like to test your search engine if the bot is able to perform a wider search with multiple hits vs having to search sequentially especially connecting predicates in a single search once you input as you suggested "insomnia" as search criteria..
https://www.fda.gov/medical-devices/classify-your-medical-device/download-product-code-classification-files#file
It contains 18 elements and "indication" is one of them.
Thanks,
Umang Shah PhD MBA RAC
US Head, Regulatory Affairs
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Umang Shah PhD, RAC
US Head Regulatory CMC Biologics
Marietta GA
United States
Original Message:
Sent: 25-Sep-2020 01:48
From: Michelle Wu
Subject: How do you search FDA medical device database?
Dear Umang
Yes, I use FDA databases and they are great. One thing though is that they don't allow users to search by indications for use. Take "insomnia" as an example, if I use 510k database and search "insomnia" in the device name box, there will be no results, because there is no device with "insomnia" in their brand names. Of course, experienced professionals can find devices via product code and other ways, still it is very convoluted.
So my team has mined out the data of devices to search by indications, would like to get more feedback.
Thanks,
Michelle
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Michelle Wu
Palo Alto CA
United States
Original Message:
Sent: 16-Sep-2020 11:08
From: Umang Shah
Subject: How do you search FDA medical device database?
Hi Michelle,
Typically the following FDA site is a good starting for such information. Would be interested to know more about your search engine.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Umang Shah PhD
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Umang Shah PhD, RAC
US Head Regulatory CMC Biologics
Marietta GA
United States
Original Message:
Sent: 15-Sep-2020 18:57
From: Michelle Wu
Subject: How do you search FDA medical device database?
Hi all
Hope you, your family, and loved ones are all safe, healthy, and happy during this tender and trying time.
We are a team of students from Stanford, Indiana U, and Georgia Tech, we are curious how you search for insight from FDA medical device databases. We prototyped a search engine that mined out all the indications for use and connect the predicates among different devices, we are curious to know if such a search engine will help you in your day-to-day work and what insight/data you are trying to find.
Thanks!
Michelle
danw2@alumni.gsb.stanford.edu