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Standard Pharmaceutical Product and Medical Device Information (Rx Product Only)
Version 2021Introduction Type:New ItemPRODUCT INFORMATION
Company Name:
Paramedics Pharma LLC
Application Number for
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How to fill out medical device de novo
How to fill out medical device de novo
01
Obtain the de novo request form from the FDA website.
02
Fill out the form with detailed information about the medical device, including its intended use and indications for use.
03
Provide a description of the device design, including its components and materials.
04
Include any testing and validation data that supports the safety and effectiveness of the device.
05
Submit the completed form to the FDA for review and evaluation.
Who needs medical device de novo?
01
Manufacturers of medical devices that are new and not substantially equivalent to existing devices on the market may need to seek de novo classification from the FDA.
02
This process is often used for low-to-moderate risk devices that do not fit into an existing device classification.
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What is medical device de novo?
Medical device de novo is a classification pathway for low to moderate risk medical devices that do not have a predicate device on the market.
Who is required to file medical device de novo?
Manufacturers of new medical devices that do not fit within an existing classification are required to file medical device de novo.
How to fill out medical device de novo?
To fill out a medical device de novo submission, manufacturers must provide detailed information on the device's intended use, design, performance, and risks.
What is the purpose of medical device de novo?
The purpose of medical device de novo is to create a pathway for innovative medical devices to enter the market without an existing predicate device.
What information must be reported on medical device de novo?
Manufacturers must report detailed information on the device's design, performance, intended use, and any potential risks or hazards.
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