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The document provides the 510(k) summary of safety and effectiveness for the SONOACE R3 Diagnostic Ultrasound System, intended for diagnostic ultrasound imaging and fluid analysis of the human body,

How to fill out 510k premarket notification

How to fill out 510(k) Premarket Notification

1. Gather necessary device information including intended use and specifications.
2. Identify the appropriate regulatory pathway based on device classification.
3. Conduct a search in the FDA database to find any predicate device.
4. Prepare a summary of the similarities and differences from the predicate device.
5. Compile required documentation including labeling, performance testing results, and risk analysis.
6. Complete the 510(k) application form accurately.
7. Submit the application electronically through the FDA's eSubmitter tool.
8. Pay the required user fee for the 510(k) application.
9. Respond to any FDA inquiries or requests for additional information.
10. Await FDA clearance before marketing the device.

Who needs 510(k) Premarket Notification?

1. Manufacturers of medical devices that are not exempt from premarket review.
2. Companies seeking to market a device that is substantially equivalent to an already legally marketed device.
3. Organizations introducing a new device that changes specifications or intended use.
4. Importers of medical devices that require FDA clearance.

People Also Ask about

What is a 510 K premarket notification?

Information from the Design Controls process is crucial. The FDA usually takes 30-90 days to process 510(k) submissions—however, the entire premarket notification process can take much longer. If accepted, the submission is listed in the database. Generally, Class II medical devices require a 510k submission.

What is the difference between premarket notification and 510k?

510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

When to submit a 510 K premarket notification?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

What is an exemption from the 510K premarket notification requirements?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

What is the pre market notification process?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

How long does it take for the 510 K determination in the case of traditional premarket notification?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is a section 510k premarket notification of intent?

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).

For pdfFiller’s FAQs

What is 510(k) Premarket Notification?

The 510(k) Premarket Notification is a submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a device is safe and effective in comparison to a legally marketed device.

Who is required to file 510(k) Premarket Notification?

Manufacturers of medical devices that are intended for human use and are classified as moderate to high risk under FDA regulations are required to file a 510(k) if the device is not exempt from this requirement.

How to fill out 510(k) Premarket Notification?

Filling out a 510(k) requires gathering information about the device, including its intended use, design specifications, labeling, and performance data. This information is then compiled into a format specified by the FDA and submitted through the FDA's electronic submission system.

What is the purpose of 510(k) Premarket Notification?

The purpose of 510(k) Premarket Notification is to inform the FDA about a medical device that is to be marketed, ensuring it is substantially equivalent to an existing device that is already cleared for marketing.

What information must be reported on 510(k) Premarket Notification?

Information required in a 510(k) includes the device's name, intended use, description of the device, substantial equivalence claim, labeling, and any supporting data such as safety and effectiveness information.