Get the free 510O(K) Sumnmary SP 21 This summary of 510(k) safety and effectiveness information i...

510O(K) Summary SP 21 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. The assigned 510(k) number

How to fill out 510ok sumnmary sp 21

How to fill out 510(k) summary SP 21:

1. Gather all necessary information: Before starting the process, make sure you have all the relevant information and documentation required to complete the 510(k) summary SP 21. This includes details about the medical device, its intended use, and any testing or clinical data you may have.
2. Follow the provided template: The FDA provides a specific template for the 510(k) summary SP 21, which should be used to organize and present the information. It is essential to follow this template accurately to ensure compliance and streamline the review process.
3. Provide a concise device description: Begin by providing a concise and clear description of the medical device. Include details such as its name, composition, dimensions, and intended use. Make sure to use straightforward language that can be easily understood by the reviewers.
4. Include a comparison to predicate devices: One of the key components of the 510(k) summary SP 21 is demonstrating substantial equivalence to an existing, legally marketed device. Include a detailed comparison of your device to one or more predicate devices, highlighting similarities and differences in design, materials, and performance.
5. Discuss non-clinical testing and performance: Provide a comprehensive summary of any non-clinical testing conducted on the device. This can include bench testing, biocompatibility studies, sterility testing, and other relevant evaluations. Clearly state the results of these tests and explain their significance in demonstrating the safety and effectiveness of the device.
6. Present clinical data, if available: If clinical data is available for the medical device, it should be included in the 510(k) summary SP 21. This may include studies conducted on human subjects, case reports, or relevant published literature. Explain the design and results of these studies, focusing on how they support the safety and effectiveness of the device.

Who needs 510(k) summary SP 21:

1. Medical device manufacturers: Manufacturers seeking to market a new medical device in the United States are required to submit a 510(k) summary SP 21 to the FDA. This applies to both domestic and foreign manufacturers.
2. Regulatory professionals: Regulatory professionals working in the medical device industry need to be familiar with the requirements for the 510(k) summary SP 21. They play a crucial role in ensuring that the necessary documentation is prepared and submitted correctly.
3. FDA reviewers: The FDA reviewers are responsible for evaluating the 510(k) summary SP 21 submissions. They require this document to assess the safety and effectiveness of new medical devices and determine whether they can be cleared for marketing in the United States.
4. Health care professionals: Health care professionals can benefit from understanding the importance of the 510(k) summary SP 21. This knowledge allows them to make informed decisions about using medical devices and ensures that they are using products that have been adequately assessed for safety and effectiveness.

For pdfFiller’s FAQs

What is 510ok sumnmary sp 21?

510ok summary sp 21 is a summary of a 510(k) submission, which is a premarket notification filed with the FDA for certain medical devices to demonstrate that the device is safe and effective.

Who is required to file 510ok sumnmary sp 21?

Manufacturers or distributors of certain medical devices are required to file a 510(k) submission with the FDA.

How to fill out 510ok sumnmary sp 21?

The 510(k) summary sp 21 should be filled out according to the FDA's guidelines and requirements, including providing information on the device's intended use, technology, performance data, and comparisons to similar devices.

What is the purpose of 510ok sumnmary sp 21?

The purpose of the 510(k) summary sp 21 is to provide a concise overview of the information contained in the full 510(k) submission, making it easier for the FDA to review and make a determination on the device's clearance.

What information must be reported on 510ok sumnmary sp 21?

The 510(k) summary sp 21 should include information on the device's indications for use, technological characteristics, performance testing data, comparison to predicate devices, and any modifications or special control measures.

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