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This document summarizes the 510(k) premarket notification for the Foryou NPWT NP32 Device, which is designed for negative pressure wound therapy. It includes information about the device, its intended

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and confirm it requires a 510(k) submission.
2. Gather information about the device's design, intended use, and technological characteristics.
3. Select a predicate device that has already been cleared by the FDA.
4. Determine if your device is substantially equivalent to the predicate device.
5. Prepare a summary of the device, including its description, intended use, and comparison with the predicate device.
6. Include performance data, safety information, and any clinical data if applicable.
7. Fill out the 510(k) form accurately and completely.
8. Include labeling information and proposed instructions for use.
9. Review and ensure all documentation is complete.
10. Submit the 510(k) Summary to the FDA along with the application.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that wish to market their products in the United States.
2. Companies that are introducing devices that are similar to those already on the market.
3. Any entity that intends to sell or distribute their medical device in the U.S. and needs FDA clearance.

People Also Ask about

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 is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the 510k pathway?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the purpose of a 510 K to determine?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as 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 difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

A 510(k) Summary is a document submitted to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is safe and effective and is substantially equivalent to a device already legally marketed in the United States.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that wish to market their products in the U.S. and claim they are substantially equivalent to a device already on the market are required to file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must provide their company information, device description, intended use, comparisons to the predicate device, and supporting data, including safety and effectiveness information.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to inform the FDA and the public about the medical device's safety, effectiveness, and substantial equivalence to previously marketed devices.

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

The 510(k) Summary must report device name, intended use, predicate device information, description of the device, performance data, labeling, and any additional information that may be required by the FDA.