Get the free Custom Device Exemption - Guidance for Industry and Food and ... - fda
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Sep 24, 2014 ... Questions and Answers/Examples of Custom Devices. ... a single custom device be unique both to a physician's practice and the patient's ...
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What is custom device exemption?
Custom device exemption is a regulatory process that allows certain medical devices to be exempt from premarket notification requirements.
Who is required to file custom device exemption?
Manufacturers or importers of medical devices that meet the criteria for exemption are required to file custom device exemption.
How to fill out custom device exemption?
To fill out custom device exemption, manufacturers or importers must provide information about the device, its intended use, and justification for exemption.
What is the purpose of custom device exemption?
The purpose of custom device exemption is to streamline the regulatory process for low-risk medical devices.
What information must be reported on custom device exemption?
Information such as device description, intended use, basis for exemption, and contact information must be reported on custom device exemption.
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