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DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002SuperSonic Imagine 0V$XUHOLH×UXHQHU

How to fill out 003 510k summary

How to fill out 003 510k summary

1. To fill out the 003 510k summary, follow these steps:
2. Start by writing the title of the summary at the top of the document.
3. Provide a brief description of the medical device for which the 510k application is being submitted.
4. Include the intended use of the device and any indications for use.
5. Summarize the technological characteristics and performance specifications of the device.
6. Include a summary of any clinical data or studies conducted on the device.
7. Provide a summary of the device's design verification and validation activities.
8. Include a summary of any risk management activities performed for the device.
9. Provide a summary of the labeling and instructions for use of the device.
10. Include any relevant information on the device's sterilization or packaging.
11. Finally, provide a conclusion summarizing the key points of the 510k application and any additional information that may be necessary.

Who needs 003 510k summary?

1. Any medical device manufacturer or distributor planning to submit a 510k application to the U.S. Food and Drug Administration (FDA) needs to include a 003 510k summary in their submission.
2. This summary is required as part of the 510k application process and provides a concise overview of the device and its supporting information.
3. It helps the FDA reviewers quickly understand the device and its intended use, allowing for a more efficient review process.

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What is 003 510k summary?

The 003 510(k) summary is a document submitted to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device.

Who is required to file 003 510k summary?

Manufacturers of medical devices that are not exempt from premarket notification requirements must file the 003 510(k) summary.

How to fill out 003 510k summary?

To fill out the 003 510(k) summary, follow FDA guidelines which include providing detailed device information, including device description, intended use, and comparisons to predicate devices.

What is the purpose of 003 510k summary?

The purpose of the 003 510(k) summary is to provide information demonstrating that a new device is safe and effective based on its substantial equivalence to an existing device.

What information must be reported on 003 510k summary?

Information that must be reported includes device identification, the regulatory history, indications for use, description of the device, any proposed labeling, and performance testing results.