Get the free 11. 510(k) Summary - accessdata fda

OCI1 1 4 2ZOOS5O) 11. 510(k) Summary Date: February 3, 2005, Submitted by: Chronology Corp., 2 West Park Rd., Watertown, PA 19083 Contact: Nicholas J. Serial, (610) 8531130 Name of Device: Trade/Proprietary

How to fill out 11 510k summary

How to Fill Out 11 510k Summary:

1. Obtain the necessary forms: Begin by acquiring the 11 510k Summary form from the appropriate regulatory agency or website. This form is typically used for medical device submissions and requires specific information to be provided.
2. Provide general information: Start the summary by entering general details such as the manufacturer's name, device trade name, and intended use. You may also need to indicate the date of the submission and the FDA identification number.
3. Include a device description: Describe the device in detail, including its specifications, components, and technical features. Provide accurate information to help in the evaluation and review process.
4. Address predicate devices: Determine if your device has any similar, previously marketed devices (predicate devices) and provide details about them. This helps establish the device's substantial equivalence and guides the regulatory assessment.
5. Address performance characteristics and testing: Include information about the device's performance and any testing carried out to validate its functionality and safety. This can involve data from clinical studies, biocompatibility testing, performance testing, or other relevant assessments.
6. Address labeling: Describe the device's labeling, including instructions for use and any warnings or precautions. Ensure that the labeling aligns with the intended use and supports safe and effective use of the device.
7. Provide a summary of safety and effectiveness: Summarize the safety and effectiveness of the device based on available clinical data, preclinical testing, or other sources. Justify the device's suitability for the intended use and highlight any potential risks or adverse events.
8. Include any changes or modifications: Indicate any changes made to the device since the last submission, including modifications to design, manufacturing processes, or labeling. This helps track changes and provides a comprehensive overview of the device's history.
9. Prepare the necessary documentation: Attach any relevant documents, such as test reports, clinical studies, labeling, or other supporting evidence. Ensure that all documentation is accurate, up to date, and correctly organized for ease of evaluation.
10. Review and submit the completed form: Thoroughly review the filled out 11 510k Summary form to confirm all information is accurate and complete. Once verified, submit it to the appropriate regulatory agency for review and evaluation.

Who Needs an 11 510k Summary?

1. Medical device manufacturers: Manufacturers who wish to market a new or modified medical device in the United States typically need to submit an 11 510k Summary. This requirement ensures that the device is safe and effective for its intended use before being made available to healthcare professionals and patients.
2. Regulatory agencies: The Food and Drug Administration (FDA) and other regulatory bodies require the submission of 11 510k Summaries to evaluate the safety and effectiveness of medical devices. These summaries aid in determining substantial equivalence to predicate devices and assist in the regulatory decision-making process.
3. Healthcare professionals and patients: The 11 510k Summary helps healthcare professionals and patients make informed decisions regarding medical devices. By providing comprehensive information on a device's performance, safety, and intended use, healthcare professionals can choose appropriate treatment options, while patients can have confidence in the devices they are being treated with.

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What is 11 510k summary?

11 510(k) summary is a concise overview of a medical device submission that provides a brief description of the safety and effectiveness of the device.

Who is required to file 11 510k summary?

Manufacturers who are seeking clearance from the FDA to market a new medical device.

How to fill out 11 510k summary?

The 510(k) summary should include information on device description, intended use, device performance data, and comparisons to similar devices on the market.

What is the purpose of 11 510k summary?

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

What information must be reported on 11 510k summary?

Information such as device description, intended use, performance data, and comparison to predicate devices.