Module 12 Presentations

29/01/2024

Identify the Product Code

Device Class

Definition Review Panel Review Panel

Product Code XXX

Submission Type GMP exemption status Regulation Number 3 rd Party Review Recognized Concensus Std.

Applicable Controls

Intended Use

Required testing

Design Specs

…

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How to define the class of a product?

• FDA Product Classification Database • Use Keywords to try identify your product Search the Product Classification Database • Search for Premarket Approval (PMA) •Search for Premarket Notification (510k) •DeNovo •Humanitarian Device Exemption (HDE) Search for Similar Devices

FDA

•Establishment Registration and Device Listing Database Search for Similar Devices by Device Listing

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