Get the free 510 k Summary As Required by 21 section 80792 cICli 3 - accessdata fda

510 (k) Summary 3 As Required by 21 sections 807.92 (c)ICL 1. Submitter Name: SSC Surat Main 189, Moo 7, Habitat, Kanjanadit, 2. Address: Suratthani, 84160, THAILAND 3. Phone: (+66) 77 277888 4. Fax:

How to fill out 510 k summary as

How to fill out 510(k) summary:

1. Gather all necessary information and documents related to your device: This includes information about the device design, intended use, indications for use, performance data, any clinical or pre-clinical testing results, and labeling information.
2. Provide a clear and concise description of the device: Start by providing a brief overview of the device, including its intended use and how it works. Include specific details about the device's components, materials, and any unique features or characteristics.
3. Detail the performance data and testing results: Present any scientific, technical, or clinical data that demonstrates the safety and effectiveness of your device. This may include results from bench testing, animal studies, or clinical trials, if applicable. Be sure to include any limitations or potential risks associated with the device.
4. Include a comparison to a legally marketed predicate device: Identify and compare your device to a similar legally marketed device that is already on the market. Explain how your device is both similar and different from the predicate device, including any improvements or modifications.
5. Provide a summary of any non-clinical or clinical performance testing: Describe the purpose and results of any testing conducted to evaluate the device's performance, safety, or effectiveness. This may include testing for biocompatibility, sterility, electrical safety, or any other relevant testing.
6. Include labeling information and instructions for use: Provide a clear and comprehensive description of the device labeling, including instructions for use, warnings, precautions, and any other relevant information that healthcare professionals or users need to know.
7. Document any changes made to the device: If there have been any modifications or changes to the device since its initial submission or clearance, clearly document and explain these changes. Include any additional testing or data generated as a result of the modifications.
8. Review and compile all documentation: Carefully review and compile all the necessary documentation and information into a well-organized and easily accessible format. Make sure all sections are complete, accurate, and up-to-date.

Who needs a 510(k) summary:

1. Medical device manufacturers: Companies or individuals developing or manufacturing medical devices that are subject to premarket notification requirements must submit a 510(k) summary to the FDA.
2. Regulatory professionals: Professionals working in regulatory affairs or quality assurance departments within medical device companies are responsible for preparing and submitting the 510(k) summary to the FDA.
3. FDA reviewers: The FDA's Center for Devices and Radiological Health (CDRH) reviews and evaluates the 510(k) summary submitted by the manufacturer to determine whether the device is substantially equivalent to a legally marketed predicate device and can be cleared for marketing.

In summary, filling out a 510(k) summary involves gathering the necessary information and documents, describing the device and its performance data, comparing it to a predicate device, providing labeling information, and documenting any changes made to the device. This process is important for medical device manufacturers, regulatory professionals, and FDA reviewers involved in the premarket notification process.

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What is 510 k summary as?

510(k) summary is a concise presentation of the significant safety and effectiveness information in a premarket notification submission.

Who is required to file 510 k summary as?

Manufacturers of medical devices who want to introduce a new device or modify an existing one are required to file a 510(k) summary.

How to fill out 510 k summary as?

To fill out a 510(k) summary, manufacturers need to provide detailed information about the device, its intended use, comparison to similar devices, and evidence of safety and effectiveness.

What is the purpose of 510 k summary as?

The purpose of a 510(k) summary is to demonstrate to the FDA that a new medical device is substantially equivalent to a legally marketed device and therefore safe and effective for its intended use.

What information must be reported on 510 k summary as?

Information such as device description, intended use, technological characteristics, performance data, labeling and instructions for use, and any clinical data must be reported on a 510(k) summary.