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Medical Device Classification Product Codes Guidance for Industry and Food and Drug Administration Staff Document issued on: April 11, 2013, The draft of this document was issued on January 3, 2012.

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What is medical device classification?

Medical device classification is the process of categorizing medical devices based on their level of risk. This classification helps regulatory authorities and healthcare professionals determine the appropriate level of oversight and control required for each device.

Who is required to file medical device classification?

Manufacturers and distributors of medical devices are required to file medical device classification. They need to provide necessary information and documentation to the regulatory authorities to determine the classification of their devices.

How to fill out medical device classification?

To fill out medical device classification, manufacturers and distributors need to gather and provide information about the device, its intended use, design, materials, and any potential risks or hazards associated with its use. This information is then submitted to the regulatory authorities according to their specific requirements.

What is the purpose of medical device classification?

The purpose of medical device classification is to ensure that medical devices are regulated and controlled based on their level of risk. It helps in ensuring patient safety, proper monitoring, and appropriate regulatory control of devices, depending on their potential risks and intended uses.

What information must be reported on medical device classification?

The information required to be reported on medical device classification may vary depending on the regulatory authority. Generally, it includes details about the device, its intended use, design, materials, and any potential risks or hazards associated with its use. Additional information such as clinical data, performance evaluations, and labeling may also be required.