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This document provides a summary of the 510(k) submission for the Digital Ultrasound Scanner WED-3100, detailing its sponsor information, device description, intended use, testing conclusions, safety

How to fill out 510k report - accessdata

How to fill out 510(k) Report

1. Determine if your device is subject to 510(k) requirements.
2. Identify the appropriate predicate device.
3. Gather all necessary information about your device, including intended use and technological characteristics.
4. Prepare a summary of safety and effectiveness data.
5. Compile labeling information, including instructions for use.
6. Complete the 510(k) cover sheet.
7. Organize all documentation and data in a clear format.
8. Submit the 510(k) report to the FDA through the appropriate channels.

Who needs 510(k) Report?

1. Manufacturers of medical devices that are not exempt and wish to market their products in the U.S.
2. Companies introducing a new device that is similar to an existing, legally marketed device.

People Also Ask about

What happens after 510k clearance?

Once a device receives clearance, a company has 30 days to register the device with the FDA. If the company is new and has no devices on the market, it must also register as an establishment with the FDA, which incurs an annual fee. Some firms are surprised to learn that additional fees are involved in this process.

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What are the requirements for 510k clearance?

The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.

What is 510k summary report?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

What are the three types of 510k?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What does 501k clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

For pdfFiller’s FAQs

What is 510(k) Report?

The 510(k) Report is a premarket submission made to the FDA to demonstrate that a device is safe and effective. It shows that the device is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Report?

Manufacturers of medical devices that are not exempt from 510(k) requirements and seek to market their devices in the U.S. are required to file a 510(k) Report.

How to fill out 510(k) Report?

To fill out a 510(k) Report, manufacturers need to complete a series of required forms, providing detailed information about the device, its intended use, and data supporting its safety and effectiveness.

What is the purpose of 510(k) Report?

The purpose of the 510(k) Report is to ensure that the medical device is safe and effective for its intended use while maintaining regulatory oversight.

What information must be reported on 510(k) Report?

Information that must be reported includes device description, intended use, technological characteristics, labeling, and data from performance testing that demonstrates substantial equivalence.