Get the free 510(K) Summary (per 21 CFR 807.92) - FDA

Reattachment 3: 51 0(k) Summary Special 510(k) Submission Gladiator Elite PTA Balloon Dilatation Catheter04A31K1 32810510(k) Summary per 21 CFR 807.92 Submitter's Name and Address Boston Scientific

How to fill out 510k summary per 21

How to fill out 510k summary per 21

1. Begin by gathering all the necessary documentation and information related to your medical device.
2. Start by preparing the cover letter, which should include the purpose of the submission and a brief summary of the device.
3. Fill out the administrative sections of the 510(k) summary, providing all the required details about the submitter, device manufacturer, and contact information.
4. Include a detailed description of the device, its intended use, and its technological characteristics.
5. Provide information about the device's indications for use, including a comprehensive list of the medical conditions it is designed to diagnose, treat, or prevent.
6. Outline the device's performance specifications, including any relevant testing methods and results.
7. Include details about the device's design, including its materials, components, and manufacturing process.
8. Summarize any non-clinical testing, such as biocompatibility studies or electrical safety evaluations.
9. Provide a summary of any clinical data and/or published literature that supports the device's safety and effectiveness.
10. Conclude the summary with a statement of compliance with relevant regulations and standards.
11. Review the completed 510(k) summary for accuracy and completeness before submitting it to the appropriate regulatory authority.

Who needs 510k summary per 21?

1. Manufacturers of medical devices that are subject to FDA regulations in the United States need to prepare a 510(k) summary per 21. This summary is necessary when seeking clearance for a new medical device or modification to an existing device. It provides a comprehensive overview of the device and its supporting documentation, helping the FDA assess the device's safety and effectiveness.

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What is 510k summary per 21?

510k summary per 21 is a concise overview of the safety and effectiveness of a medical device submitted to the FDA for clearance.

Who is required to file 510k summary per 21?

Manufacturers of medical devices seeking FDA clearance are required to file 510k summary per 21.

How to fill out 510k summary per 21?

To fill out 510k summary per 21, manufacturers must provide detailed information about the device, including its intended use, design, and testing results.

What is the purpose of 510k summary per 21?

The purpose of 510k summary per 21 is to demonstrate to the FDA that a medical device is safe and effective for its intended use.

What information must be reported on 510k summary per 21?

Information such as device description, intended use, design, materials, performance data, labeling, and biocompatibility must be reported on 510k summary per 21.