Get the free Medical Device Listing Application

Medical Device Division Department of Health Medical Device Administrative Control System Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) For official use only Date Received:___Application

How to fill out medical device listing application

How to fill out medical device listing application

1. Gather all necessary information such as device name, owner/operator information, FDA registration number, and device classification.
2. Submit a premarket notification (510(k)) to the FDA if required for your device.
3. Complete Form FDA 2891 for medical device listing and submit to the FDA.
4. Pay the applicable fee for listing your medical device.
5. Update your listing annually and whenever changes occur.

Who needs medical device listing application?

1. Manufacturers of medical devices who intend to market their products in the United States.
2. Distributors or importers of medical devices who want to introduce new devices into the US market.
3. FDA-accredited third-party reviewers who are responsible for reviewing and submitting applications on behalf of manufacturers.

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What is medical device listing application?

A medical device listing application is a submission made to a regulatory authority, such as the FDA, to register a medical device and to provide information about its classification, manufacturing, and intended use.

Who is required to file medical device listing application?

Manufacturers and importers of medical devices are required to file a medical device listing application to ensure that their products comply with regulatory standards and can be marketed in a particular jurisdiction.

How to fill out medical device listing application?

To fill out a medical device listing application, one must provide detailed information about the device, including its name, intended use, labeling, and manufacturing processes, along with the appropriate regulatory fees and supporting documentation.

What is the purpose of medical device listing application?

The purpose of a medical device listing application is to ensure that all medical devices on the market are safe and effective, to maintain a database of medical devices, and to provide transparency in the device approval process.

What information must be reported on medical device listing application?

Information that must be reported includes the device name, registration number, intended use, classification, manufacturing details, and any associated labeling or promotional materials.