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This document provides a summary of the 510(k) premarket notification for the AC Wound Management System, detailing device specifications, indications for use, comparative analysis with predicate

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device type and ensure it requires a 510(k) submission.
2. Gather information on the device, including its intended use and technological characteristics.
3. Conduct a comparison with a legally marketed predicate device to establish substantial equivalence.
4. Prepare detailed descriptions of the device, including materials, design, and manufacturing processes.
5. Include performance testing data, if applicable, to demonstrate safety and effectiveness.
6. Ensure all labeling and promotional materials comply with FDA requirements.
7. Complete the necessary forms and submit the 510(k) to the FDA, including the Summary.

Who needs 510(k) Summary?

1. Manufacturers or importers of medical devices that are not exempt from premarket notification requirements.
2. Companies introducing a new device that is similar to an existing, legally marketed device (predicate).
3. Entities seeking to make modifications to a currently marketed device that could affect its safety or effectiveness.

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?

The 510(k) Summary is a document submitted to the FDA that provides detailed information about a medical device, including its intended use, technological characteristics, and performance data to demonstrate that it is safe and effective.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are classified as Class I (with some exceptions) and Class II are generally required to file a 510(k) Summary before marketing their products.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must gather and organize information about the device, such as its description, intended use, labeling, and any relevant performance testing, and then complete the 510(k) form available on the FDA website.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the medical device is substantially equivalent to an already marketed device, thereby ensuring safety and effectiveness for public use.

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

The 510(k) Summary must include information such as the applicant's details, device name and classification, intended use, descriptions of technological characteristics, comparisons to predicate devices, and any performance test results.