Get the free 510(k) template

DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002Philips Healthcare 0U0DUNRE

How to fill out 510k template

How to fill out 510k template

1. To fill out a 510k template, follow these steps:
2. Begin by downloading the 510k template from the appropriate regulatory authority's website.
3. Fill in the general information section, including the name and contact information of the submitter.
4. Provide a concise description of the medical device for which the 510k application is being submitted.
5. Include details about the device's intended use, indications for use, and any relevant technological characteristics.
6. Provide a summary of any nonclinical and clinical testing conducted on the device, including the results of these tests.
7. Include information on any modifications or changes made to the device, as well as a rationale for why the modifications are not substantial.
8. Fill in the section regarding previous Substantial Equivalence (SE) determination, if applicable.
9. Include any relevant labeling or graphical materials as attachments or appendices to the 510k template.
10. Review the completed template for accuracy and completeness, ensuring all required information is provided.
12. Please note that these are general guidelines and it is highly recommended to consult the specific regulatory authority's guidelines for filling out the 510k template.

Who needs 510k template?

1. The 510k template is required by medical device manufacturers who intend to market or sell a medical device in the United States.
2. It is necessary for companies to submit a 510k application to the U.S. Food and Drug Administration (FDA) to demonstrate that their device is substantially equivalent to a legally marketed device.
3. Without a completed 510k template, manufacturers may not be able to obtain clearance to market their medical device in the U.S.
4. Therefore, any medical device company seeking to sell or distribute a new medical device in the U.S. market needs to fill out a 510k template.

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What is 510k template?

The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

Who is required to file 510k template?

Medical device manufacturers planning to market a new medical device that is not substantially equivalent to a previously cleared device are required to file a 510(k) template.

How to fill out 510k template?

To fill out a 510(k) template, the manufacturer must provide detailed information about the device, its intended use, technological characteristics, and demonstrate how it is substantially equivalent to a previously cleared device.

What is the purpose of 510k template?

The purpose of the 510(k) template is to demonstrate to the FDA that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety and effectiveness.

What information must be reported on 510k template?

The 510(k) template must include information about the device, its intended use, performance data, comparisons to previously cleared devices, labeling, and any other relevant information to demonstrate substantial equivalence.