Get the free SPECIAL 510(k): Device Modification

This 510 k was received and reviewed under the policy for bundling and contains information for 11 separate assays K022992 REAADS anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit 2 assays K022990 REAADS IgA anti-Cardiolipin Semi-Quantitative Test Kit K024196 REAADS anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit K024195 REAADS IgA anti-Phosphatidylserine Semi-Quantitative Test Kit K031208 REAADS IgG anti-Beta 2 Glycoprotein I Semi-quantitative Test Kit 2. The sponsor also...

How to fill out special 510k device modification

How to fill out special 510k device modification

1. Gather all necessary information and documents required for the special 510k device modification application.
2. Ensure that you have a complete understanding of the device modification you are proposing.
3. Identify the specific section of the Special 510k guidance document that applies to your device modification.
4. Prepare a detailed description of the device modification, including the purpose, materials used, and any potential risks or benefits.
5. Complete the necessary forms and provide all required information, including device labeling, testing data, and clinical trial results if applicable.
6. Submit the completed application to the appropriate regulatory authority.
7. Monitor the progress of your application and respond promptly to any requests for additional information or clarification.
8. If your application is approved, implement the device modification according to the approved specifications and update your device labeling accordingly.
9. Keep detailed records of the device modification process and any post-market surveillance activities.
10. Periodically review the safety and effectiveness of the modified device and report any adverse events or issues to the regulatory authority as required.

Who needs special 510k device modification?

1. Manufacturers of medical devices that have already received FDA clearance or approval and wish to make modifications to their device.
2. Manufacturers of medical devices that require a new 510k submission due to significant changes that could affect safety or effectiveness.
3. Manufacturers of medical devices that are adding new indications for use or changing the device's intended use.
4. Manufacturers of medical devices that wish to update their device labeling or packaging.
5. Manufacturers of medical devices that have received feedback or recommendations from the regulatory authority to modify their device.

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What is special 510k device modification?

Special 510k device modification is a process where a manufacturer makes changes or modifications to a previously cleared medical device under a special 510(k) submission, instead of a traditional 510(k) submission.

Who is required to file special 510k device modification?

Manufacturers who want to make changes to their already cleared medical devices that could significantly affect the safety or effectiveness of the device are required to file special 510(k) device modification.

How to fill out special 510k device modification?

To fill out special 510k device modification, manufacturers must provide a detailed description of the changes made, along with any test data or other information to support the safety and effectiveness of the modified device.

What is the purpose of special 510k device modification?

The purpose of special 510k device modification is to provide a streamlined process for manufacturers to make modifications to already cleared medical devices while ensuring the safety and effectiveness of the modified device.

What information must be reported on special 510k device modification?

Manufacturers must report detailed information about the modifications made to the device, any new risks introduced, and any data supporting the safety and effectiveness of the modified device.