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FEB Section C 510(k) Summary '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)
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How to fill out section c 510k summary
How to fill out section c 510k summary:
01
Begin by providing a concise and clear summary of the intended use of the medical device. This should include the primary function and purpose of the device.
02
Describe any similarities or differences between the device in question and other devices that are already on the market. Include information on any competitive products and their features.
03
Provide a detailed outline of the device's technological characteristics, including its design, materials used, and any unique components or features.
04
Explain any clinical testing or studies conducted on the device to demonstrate its safety and effectiveness. Include information on the study design, sample size, and any statistical analysis performed.
05
State any labeling claims associated with the device, including indications, contraindications, warnings, and precautions. Ensure that all claims are supported by appropriate evidence and are consistent with the device's intended use.
06
Include information on the device's shelf life, storage conditions, and any necessary precautions for handling or disposing of the device.
07
Finally, provide a summary of any additional information or data that is relevant to the device's clearance or approval.
Who needs section c 510k summary:
01
Medical device manufacturers who are seeking clearance or approval for their devices from the U.S. Food and Drug Administration (FDA) are required to provide a section c 510k summary as part of their submission.
02
Regulatory affairs professionals who are responsible for preparing and submitting 510k applications on behalf of medical device manufacturers.
03
Quality assurance professionals who need to review and verify the accuracy and completeness of the section c 510k summary before submission.
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What is section c 510k summary?
Section C 510k summary is a part of premarket notification submission that provides a concise summary of the safety and effectiveness of a medical device.
Who is required to file section c 510k summary?
Manufacturers or sponsors of medical devices are required to file section C 510k summary.
How to fill out section c 510k summary?
Section C 510k summary should be filled out by providing relevant information on the safety and effectiveness of the medical device in a clear and concise manner.
What is the purpose of section c 510k summary?
The purpose of section C 510k summary is to provide a quick overview of the device's safety and effectiveness for regulatory review.
What information must be reported on section c 510k summary?
Section C 510k summary must include information on the device description, indications for use, summary of safety and effectiveness data, and any applicable regulatory standards.
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