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JAN 1 4 2013 3. 510(k) Summary The CDC hereby submits this special 5 10(k) in accordance with the requirements of SODA 1990 and 21 CFR 807.92. Submitter Centers for Disease Control and Prevention
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How to fill out section 3 510k summary
How to fill out section 3 510k summary
01
To fill out section 3 510k summary, follow these steps:
02
Start by providing a brief description of the device, including its intended use and any other relevant information.
03
Include a summary of any performance testing or clinical studies that have been conducted on the device.
04
Provide a summary of any adverse events that have been reported for the device.
05
Include a summary of any modifications that have been made to the device since its original approval or clearance.
06
Finally, include any other relevant information or supporting data that will help to support the safety and effectiveness of the device.
Who needs section 3 510k summary?
01
Section 3 510k summary is needed by medical device manufacturers who are seeking clearance or approval from the FDA for their devices.
02
It is required as part of the 510k submission process and is used to provide a concise summary of the safety and effectiveness of the device being submitted.
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What is section 3 510k summary?
Section 3 of a 510k summary in medical device regulation is the Indications for Use Statement.
Who is required to file section 3 510k summary?
The manufacturer of the medical device is required to file section 3 of the 510k summary.
How to fill out section 3 510k summary?
To fill out section 3 of the 510k summary, the manufacturer must provide a clear and concise statement of the intended use of the medical device.
What is the purpose of section 3 510k summary?
The purpose of section 3 of the 510k summary is to provide a detailed description of the intended use of the medical device.
What information must be reported on section 3 510k summary?
Section 3 of the 510k summary must contain information about the indications for use of the medical device.
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