List of Contributions

Michelle Wu

Contact Details

United States

Contributions

1 to 5 of 6 total
Posted By Michelle Wu 29-Sep-2020 20:52
Found In Egroup: Atlanta Chapter
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Awesome! Happy to demo and hear feedback from experts like you:) ------------------------------ Michelle Wu Palo Alto CA United States ------------------------------
Posted By Michelle Wu 29-Sep-2020 20:50
Found In Egroup: Atlanta Chapter
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Dear Diane Good suggestion. Can I ask how often will people already have a predicate in mind and find the product code then search for the devices? I want to understand, say, xyz% of users already know which predicates to use v.s.  % of users not sure and want to search for a predicates, if the number ...
Posted By Michelle Wu 29-Sep-2020 20:45
Found In Egroup: Atlanta Chapter
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Hi Jeffrey You are absolutely right. Searching for a product code based on indications to use is not necessary since the FDA product code database is already good enough. If my goal is to find a device that has specific indications to use, say, insomnia, then the product code database may not help ...
Posted By Michelle Wu 29-Sep-2020 20:32
Found In Egroup: Atlanta Chapter
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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 ...
Posted By Michelle Wu 25-Sep-2020 01:48
Found In Egroup: Atlanta Chapter
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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" ...