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510(k) Submissions Workshop Courtyard Irvine Spectrum, Irvine, CA February 2728, 2017 February 27, 2017 8:30 9:00 registration Checking and Continental Breakfast9:00 9:05 welcome and Introductions9:05
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What is 510k submissions workshop?
510k submissions workshop is a workshop designed to provide guidance on the process of submitting a premarket notification (510k) to the FDA for certain medical devices.
Who is required to file 510k submissions workshop?
Manufacturers of medical devices that are subject to premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act are required to file 510k submissions workshop.
How to fill out 510k submissions workshop?
To fill out 510k submissions workshop, manufacturers must provide detailed information about the device, including its intended use, design, materials, and labeling, as well as any data supporting its safety and effectiveness.
What is the purpose of 510k submissions workshop?
The purpose of 510k submissions workshop is to demonstrate that a medical device is substantially equivalent to a legally marketed device and therefore does not require premarket approval by the FDA.
What information must be reported on 510k submissions workshop?
Information that must be reported on 510k submissions workshop includes a description of the device, its intended use, its technological characteristics, a comparison to similar devices on the market, and any testing data.
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