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Device Guidance Page 1 of 2 If FDA has made a determination, the determination can be accepted by the IRB e.g. approved IDE, cleared 510(k). 1. Medical Device Determination: Is the device a medical

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What is device guidance page 1?

Device guidance page 1 is a form that provides instructions and information for manufacturers about the regulatory requirements for a particular medical device.

Who is required to file device guidance page 1?

Manufacturers of medical devices are required to file device guidance page 1.

How to fill out device guidance page 1?

Device guidance page 1 can be filled out by following the instructions provided on the form and providing all required information about the medical device.

What is the purpose of device guidance page 1?

The purpose of device guidance page 1 is to ensure that manufacturers comply with regulatory requirements and provide accurate information about their medical devices.

What information must be reported on device guidance page 1?

Information such as device classification, intended use, design specifications, risk analysis, and labeling must be reported on device guidance page 1.

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