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Revised 510(K) PREMARKET NOTIFICATION SUMMARY Name/Address of submitter: OT medical GmbH KonsulSmidtStr. 8b D28217 Bremen/Germany Establishment Registration Number: 10033109 Contact Person: Nov 1

How to fill out revised 510k premarket notification

How to fill out revised 510k premarket notification:

1. Gather all the necessary information and documentation required for the 510k submission. This includes details about the device, its intended use, technological characteristics, and any previous submissions or clearances.
2. Start by correctly identifying the type of submission you are making, whether it is a complete or abbreviated submission, and if it is a new or changed submission. This will determine the specific forms and requirements that are applicable.
3. Begin the notification by completing the administrative information, such as the contact details of the submitter, the device manufacturer, and any authorized representatives involved in the submission process.
4. Provide a detailed description and specifications of the device, including its components, materials used, manufacturing process, and any accessories or software associated with it.
5. Address the intended use of the device and provide a clear description of the patient population it is intended for, the conditions it will be used to diagnose, monitor, or treat, and any contraindications or warnings that should be considered.
6. Include a comprehensive analysis of the device's safety and effectiveness, supported by scientific data, clinical studies, or any relevant literature or data sources. Ensure all risks are identified and mitigated, and provide sufficient evidence to demonstrate that the device is safe and reliable for its intended purpose.
7. Discuss any changes made to the device or its manufacturing process compared to previously cleared submissions, if applicable. This may require additional documentation or evidence to address any potential impact on safety or performance.
8. Submit samples of the device or any necessary labeling or packaging materials, as requested or required by regulatory authorities.
9. Include a detailed summary of any proposed labeling, such as instructions for use, warnings, precautions, and any promotional materials, ensuring compliance with applicable regulations and standards.
10. Finally, submit the completed 510k premarket notification along with any requested fees to the appropriate regulatory authority, such as the U.S. Food and Drug Administration (FDA).

Who needs revised 510k premarket notification?

A revised 510k premarket notification may be needed by medical device manufacturers who have made changes to a previously cleared device that may affect its safety or effectiveness. This can include modifications to the device's design, materials, labeling, intended use, or manufacturing process. The revised notification allows the manufacturer to provide updated information to regulatory authorities to evaluate the impact of these changes and determine if the device still meets the necessary regulatory standards. The need for a revised 510k premarket notification will depend on the specific nature and significance of the changes made, as well as the requirements of the regulatory jurisdiction where the device is being marketed.

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What is revised 510k premarket notification?

Revised 510k premarket notification is a submission made to the FDA for certain changes made to a medical device that has already been cleared through the 510(k) process.

Who is required to file revised 510k premarket notification?

Manufacturers of medical devices are required to file a revised 510k premarket notification if changes have been made to a previously cleared device.

How to fill out revised 510k premarket notification?

The revised 510k premarket notification should be filled out following the FDA's guidelines and including all the necessary information about the changes made to the device.

What is the purpose of revised 510k premarket notification?

The purpose of the revised 510k premarket notification is to inform the FDA about changes made to a medical device to ensure its safety and effectiveness.

What information must be reported on revised 510k premarket notification?

The revised 510k premarket notification should include information about the changes made to the device, any new risks identified, and any new data or test results obtained.