Get the free JA N 5 510k Summary - Food and Drug Administration - accessdata fda

JA N 2 72014 5. 510(k) Summary 5.1 Description Dimensions Creatinine (CRE2) Flex reagent cartridge This summary of 51 0(k) safety and effectiveness information is submitted in accordance with the

How to fill out ja n 5 510k

1. To fill out the Ja N 5 510k form, start by gathering all the necessary information and documentation. This includes details about the medical device, its intended use, and any previous submissions or clearances.
2. Begin by filling out the basic information section of the form, such as the company name, address, and contact details. Provide accurate and up-to-date information to ensure smooth communication throughout the process.
3. In the Device Identification section, describe the device thoroughly, including its intended use, technical specifications, and any labeling information. This section is crucial to clearly define the device and its purpose.
4. In the Submitter section, provide the name, address, and contact details of the company or person responsible for submitting the 510k application. If there are multiple contacts, indicate their respective roles and responsibilities.
5. Proceed to the Administrative Information section, where you will fill out details regarding the type of submission, such as initial application or re-submission, as well as any previous clearances or exemptions received.
6. The Predicate Devices section requires you to list any and all devices that serve as a basis for substantial equivalence comparison. Include the name, model, and any relevant information about these predicate devices.
7. In the Substantial Equivalence section, provide a detailed comparison between your device and the predicate devices mentioned earlier. State the similarities and differences, highlighting why your device is substantially equivalent in terms of safety and effectiveness.
8. Complete the Nonclinical Engineering Tests section by describing the nonclinical testing conducted on the device, including performance, biocompatibility, and any other relevant evaluations. Provide a summary of the test results and supporting data.
9. In the Bioresearch Monitoring Information section, indicate whether any human or animal studies were conducted, and provide details of these studies. Include information about the Institutional Review Board (IRB) approval and any adverse events encountered during the research.
10. Submit any additional documentation required with the application, such as labeling, manufacturing information, or clinical data. Ensure that all supporting materials are accurate, complete, and well-organized for efficient review.

Who needs Ja N 5 510k?

1. Medical device manufacturers who are seeking to market a new medical device in the United States generally need to submit a Ja N 5 510k application.
2. This form is required by the Food and Drug Administration (FDA) to assess the safety and effectiveness of the device and determine if it is substantially equivalent to a legally marketed device.
3. Manufacturers who intend to modify a previously cleared device may also need to submit a Ja N 5 510k to demonstrate that the modifications do not compromise the safety or effectiveness of the device.
4. It is important to consult the FDA's guidelines and regulations to determine if your specific device requires a Ja N 5 510k submission.

For pdfFiller’s FAQs

What is ja n 5 510k?

Ja n 5 510k is a premarket notification submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is substantially equivalent to a previously cleared device.

Who is required to file ja n 5 510k?

Manufacturers planning to market a new medical device or modify an existing device that does not require a premarket approval (PMA) are required to file a ja n 5 510k.

How to fill out ja n 5 510k?

To fill out a ja n 5 510k, the manufacturer needs to provide information on the device, its intended use, performance data, and comparison to a predicate device. Detailed instructions can be found on the FDA's website.

What is the purpose of ja n 5 510k?

The purpose of ja n 5 510k is to demonstrate that a new or modified medical device is as safe and effective as a legally marketed device that does not require premarket approval.

What information must be reported on ja n 5 510k?

Information reported on a ja n 5 510k includes device description, intended use, technological characteristics, performance data, and comparison to a legally marketed predicate device.

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