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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 February 12, 2016, Active

How to fill out 510k summary of safety

How to fill out a 510k summary of safety:

1. Obtain a copy of the 510k summary of safety template from the appropriate regulatory authority.
2. Start by providing the necessary identification information, such as the device name, manufacturer's name, and the 510k number.
3. Include a brief description of the device, its intended use, and its technological characteristics.
4. Compile a list of all the risks associated with the device, considering potential hazards, adverse events, and possible harm to patients, users, or other individuals.
5. Describe the mitigations and controls implemented to minimize these risks, including design features, labeling instructions, warnings, and precautions.
6. Include any relevant clinical data or studies that support the device's safety claims.
7. Provide a summary of the results from any non-clinical and clinical testing conducted, highlighting any adverse events or safety concerns encountered.
8. Include a section on previous or similar marketed devices that can be used as a basis for comparison to establish the safety profile of the new device.
9. Clearly state the intended population for which the device is intended and any specific patient populations that may have increased risks.
10. Finalize the summary by acknowledging any limitations, remaining uncertainties, or ongoing post-market surveillance plans.

Who needs a 510k summary of safety?

1. Medical device manufacturers who are seeking clearance for their devices through the 510k premarket notification pathway.
2. Regulatory authorities such as the U.S. Food and Drug Administration (FDA) who review and evaluate the safety and effectiveness of medical devices prior to market approval.
3. Health care professionals who may use or prescribe the device and need comprehensive safety information to make informed decisions for their patients.
4. Patients and patient advocacy groups who may have an interest in understanding the safety and risks associated with medical devices for their own health management or advocacy purposes.

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What is 510k summary of safety?

The 510(k) summary of safety is a document submitted to the FDA that summarizes the safety and effectiveness of a medical device.

Who is required to file 510k summary of safety?

Manufacturers of medical devices who are seeking FDA approval to market their products in the United States are required to file a 510(k) summary of safety.

How to fill out 510k summary of safety?

The 510(k) summary of safety should be filled out with detailed information on the safety and effectiveness of the medical device, including any clinical data and testing results.

What is the purpose of 510k summary of safety?

The purpose of the 510(k) summary of safety is to provide the FDA with a concise overview of the safety and effectiveness of a medical device in order to support the approval process.

What information must be reported on 510k summary of safety?

The 510(k) summary of safety must include information on the device design, materials, performance, biocompatibility, and any clinical data or testing results.