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Special 510(k) Premarket Notification SEP 2 1 2005 Ac514# GE LOGIC 7 Ultrasound BT05 September 2, 2005, Attachment B: Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

How to fill out special 510k premarket notification

1. Begin by gathering all necessary information and documentation for your special 510k premarket notification. This may include details about the medical device, its intended use, the manufacturing process, and any previous clearance or approvals.
2. Prepare the required forms and documents, including the completed FDA Form 3514. Ensure that all sections are accurately filled out, providing clear and concise information.
3. Include a cover letter explaining the purpose of the notification and any supporting documentation that strengthens your case for clearance. This may include clinical data, test reports, or any other relevant evidence.
4. Conduct a thorough analysis of the risks associated with your medical device and provide a detailed risk assessment. Include any mitigation measures or strategies that have been implemented to minimize these risks.
5. Address any potential labeling issues or concerns, ensuring that the information provided accurately reflects the device's intended use and any potential hazards or warnings.
6. Ensure compliance with applicable regulations and guidelines, such as the Quality System Regulation (QSR) and Design Control requirements. Document any steps taken to establish and maintain a robust quality management system.
7. Attach a Declaration of Conformity, stating that the device complies with all applicable FDA regulations and standards. Any exceptions or deviations should be clearly justified and supported by appropriate evidence.
8. Verify that all supporting documentation and information provided is complete, accurate, and up to date. Double-check for any missing or incorrect information that could hinder the review process.
9. Submit the completed special 510k premarket notification package to the FDA via the appropriate means, following their submission guidelines and timelines.

Who needs special 510k premarket notification?

1. Manufacturers of medical devices that intend to market new or modified devices that have the same intended use as legally marketed devices but may raise different questions of safety and effectiveness.
2. Manufacturers of devices subject to the Special Controls Guidance Document, which outline additional requirements for certain types of devices.
3. Companies looking to obtain marketing clearance for significant modifications to existing devices that may affect the device's safety or effectiveness.

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What is special 510k premarket notification?

Special 510k premarket notification is a pathway for medical device manufacturers to demonstrate compliance with FDA regulations before marketing a new device.

Who is required to file special 510k premarket notification?

Manufacturers of medical devices that require FDA clearance before marketing are required to file special 510k premarket notification.

How to fill out special 510k premarket notification?

Special 510k premarket notification can be filled out online through the FDA's electronic submission system, by providing detailed information about the device and its intended use.

What is the purpose of special 510k premarket notification?

The purpose of special 510k premarket notification is to demonstrate that a new medical device is as safe and effective as a legally marketed device, while accounting for the differences in technology or method of use.

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

Special 510k premarket notification must include information about the device's design, performance data, labeling, and any other relevant details to demonstrate substantial equivalence to a legally marketed device.